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Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00513461
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Adult Primary Liver Cancer
Hepatitis C Infection
Interventions Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Other: placebo
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: high performance liquid chromatography
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Period Title: Overall Study
Started 57 53
Completed 44 43
Not Completed 13 10
Arm/Group Title Arm I (SAMe) Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 57 53 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 53 participants 110 participants
58.5  (4.9) 57.2  (5.8) 57.88  (5.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 53 participants 110 participants
Female
9
  15.8%
6
  11.3%
15
  13.6%
Male
48
  84.2%
47
  88.7%
95
  86.4%
1.Primary Outcome
Title Change in Serum AFP Levels
Hide Description Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: ng/mL
-1.928  (20.304) 5.855  (29.207)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SAMe), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma
Hide Description To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.259  (0.976) 0.647  (1.491)
3.Secondary Outcome
Title Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma
Hide Description AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: percentage of AFP-L3/AFP
0.144  (1.146) 0.335  (3.486)
4.Secondary Outcome
Title SAMe
Hide Description Change in SAMe levels
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: nmol/L
414.242  (744.373) -9.085  (54.621)
5.Secondary Outcome
Title Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)
Hide Description S-adenosylhomocysteine (SAH)
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: nmol/L
16.326  (28.212) -3.456  (13.104)
6.Secondary Outcome
Title Change in SAMe Metabolites - Methionine
Hide Description Methionine will be measured using HPLC with fluorescence detection.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: µmol/L
0.421  (18.794) -2.894  (23.669)
7.Secondary Outcome
Title Change in SAMe Metabolites - Total Homocysteine (tHcy)
Hide Description Total homocysteine (tHcy)
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: µmol/L
0.266  (2.394) -0.677  (2.478)
8.Secondary Outcome
Title Change in SAMe Metabolites - Plasma GSH
Hide Description Plasma GSH will be measured using HPLC with fluorescence detection.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: µmol/L
0.455  (1.425) 0.285  (1.23)
9.Secondary Outcome
Title Change in SAMe Metabolites - Malondialdehyde (MDA)
Hide Description malondialdehyde
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: µmol/L
-0.007  (0.848) -0.002  (1.162)
10.Secondary Outcome
Title Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)
Hide Description Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: µg/mL
-0.185  (0.716) -0.032  (0.448)
11.Secondary Outcome
Title Change in Markers of Liver Disease - AST
Hide Description AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: IU/L
-0.755  (37.531) 1.723  (40.709)
12.Secondary Outcome
Title Change in Markers of Liver Disease - ALT
Hide Description ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: IU/L
-9.548  (34.786) 0.019  (41.165)
13.Secondary Outcome
Title HCV RNA
Hide Description Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: IU/mL
-259327.69  (3084015.42) -19968.89  (2425010.48)
14.Secondary Outcome
Title Changes in Quality of Life - Physical Score
Hide Description Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (11.73) 0.03  (13.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SAMe), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.878
Comments [Not Specified]
Method Two-Group t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.43
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Changes in Quality of Life - Mental Score
Hide Description Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.83  (15.06) -2.83  (11.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SAMe), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Two-Group t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.66
Estimation Comments [Not Specified]
Time Frame Through study completion, an average of 30 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (SAMe) Arm II (Placebo)
Hide Arm/Group Description

Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

All-Cause Mortality
Arm I (SAMe) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (SAMe) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/57 (8.77%)      3/53 (5.66%)    
Cardiac disorders     
NON-ST ELEVATION MIOCARDIAL INFARCTION *  1/57 (1.75%)  1 0/53 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT *  1/57 (1.75%)  1 0/53 (0.00%)  0
ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATION *  1/57 (1.75%)  1 0/53 (0.00%)  0
SMALL BOWEL INFLAMATION *  1/57 (1.75%)  1 0/53 (0.00%)  0
Hepatobiliary disorders     
HEPATOCELLULAR CARCINOMA *  0/57 (0.00%)  0 1/53 (1.89%)  1
SPLENOMEGALY SECONDARY TO PORTAL HYPERTENSION *  1/57 (1.75%)  1 0/53 (0.00%)  0
Infections and infestations     
ABDOMINAL CELLULITIS *  0/57 (0.00%)  0 1/53 (1.89%)  1
LEFT THIGH ABSCESS *  0/57 (0.00%)  0 1/53 (1.89%)  1
PNEUMONIA *  1/57 (1.75%)  1 0/53 (0.00%)  0
Renal and urinary disorders     
NEPHROTIC SYNDROME *  1/57 (1.75%)  1 0/53 (0.00%)  0
Vascular disorders     
ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEG *  0/57 (0.00%)  0 1/53 (1.89%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (SAMe) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/57 (89.47%)      46/53 (86.79%)    
Blood and lymphatic system disorders     
SWELLING OF ANKLES *  1/57 (1.75%)  1 0/53 (0.00%)  0
Ear and labyrinth disorders     
CLICKING SOUND IN THE HEAD *  1/57 (1.75%)  1 0/53 (0.00%)  0
EAR PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
EARS RINGING *  0/57 (0.00%)  0 1/53 (1.89%)  1
TINNITUS *  0/57 (0.00%)  0 1/53 (1.89%)  1
Endocrine disorders     
BORDERLINE DIABETES *  1/57 (1.75%)  1 0/53 (0.00%)  0
DIABETES MELLITUS *  0/57 (0.00%)  0 1/53 (1.89%)  1
HOT FLUSHES *  1/57 (1.75%)  1 0/53 (0.00%)  0
WORSENING OF BASELINE DIABETES MELLITUS *  0/57 (0.00%)  0 1/53 (1.89%)  1
Eye disorders     
BLURRED VISION *  0/57 (0.00%)  0 1/53 (1.89%)  1
EYE PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
EYES HURT *  1/57 (1.75%)  1 0/53 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL CRAMPS *  0/57 (0.00%)  0 1/53 (1.89%)  1
ABDOMINAL DISCOMFORT *  1/57 (1.75%)  1 0/53 (0.00%)  0
ASCITES *  1/57 (1.75%)  1 2/53 (3.77%)  2
BAD GAS *  1/57 (1.75%)  1 1/53 (1.89%)  1
CHRONIC ASCITES *  0/57 (0.00%)  0 1/53 (1.89%)  1
CHRONIC GASTRITIS *  0/57 (0.00%)  0 1/53 (1.89%)  1
CONSTIPATION *  12/57 (21.05%)  17 5/53 (9.43%)  6
DENTAL IMPLANT SURGERY *  1/57 (1.75%)  1 0/53 (0.00%)  0
DIARRHEA *  20/57 (35.09%)  31 13/53 (24.53%)  17
DIARRHEA 4-6 STOOLS/DAY *  1/57 (1.75%)  1 0/53 (0.00%)  0
DIFFUSE ABDOMINAL PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
DRY MOUTH *  10/57 (17.54%)  10 12/53 (22.64%)  13
DRY MOUTH/SALIVARY GLAND *  1/57 (1.75%)  1 0/53 (0.00%)  0
DRYNESS OF MOUTH *  1/57 (1.75%)  1 0/53 (0.00%)  0
EXTRA GAS FLATULENCE *  0/57 (0.00%)  0 1/53 (1.89%)  1
FLATULENCE *  19/57 (33.33%)  22 22/53 (41.51%)  25
FOOD POISONING *  2/57 (3.51%)  2 0/53 (0.00%)  0
GAS-FLATULENCE *  1/57 (1.75%)  1 1/53 (1.89%)  1
GI CONSTIPATION *  1/57 (1.75%)  1 0/53 (0.00%)  0
GUM BLEEDING *  0/57 (0.00%)  0 1/53 (1.89%)  1
HEARTBURN *  7/57 (12.28%)  9 4/53 (7.55%)  4
INCREASE IN FLATULENCE *  1/57 (1.75%)  1 0/53 (0.00%)  0
INCREASE NUMBER OF STOOLS *  1/57 (1.75%)  1 0/53 (0.00%)  0
INCREASED DIARRHEA *  0/57 (0.00%)  0 1/53 (1.89%)  1
INCREASED FLATULENCE *  0/57 (0.00%)  0 1/53 (1.89%)  1
INCREASED STOMACH PAIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
INTESTINAL FLU *  1/57 (1.75%)  1 0/53 (0.00%)  0
NAUSEA *  18/57 (31.58%)  20 7/53 (13.21%)  8
QUEASINESS *  0/57 (0.00%)  0 1/53 (1.89%)  1
STOMACH ACHE *  1/57 (1.75%)  1 0/53 (0.00%)  0
STOMACH CRAMPS *  1/57 (1.75%)  3 0/53 (0.00%)  0
STOMACH FLU *  0/57 (0.00%)  0 1/53 (1.89%)  1
STOMACH PAIN *  21/57 (36.84%)  28 9/53 (16.98%)  10
TOOTH EXTRACTION *  1/57 (1.75%)  1 0/53 (0.00%)  0
TOOTHACHE *  1/57 (1.75%)  1 0/53 (0.00%)  0
UPSET STOMACH *  0/57 (0.00%)  0 1/53 (1.89%)  1
VOMITING *  5/57 (8.77%)  6 4/53 (7.55%)  4
General disorders     
CHILLS *  1/57 (1.75%)  1 0/53 (0.00%)  0
COLD *  4/57 (7.02%)  5 2/53 (3.77%)  2
COMMON COLD *  1/57 (1.75%)  1 1/53 (1.89%)  1
FATIGUE *  15/57 (26.32%)  19 9/53 (16.98%)  11
FEVER *  1/57 (1.75%)  1 1/53 (1.89%)  1
FLU *  1/57 (1.75%)  1 0/53 (0.00%)  0
FLU-LIKE SYMPTOMS *  0/57 (0.00%)  0 4/53 (7.55%)  4
TIREDNESS FATIGUE *  0/57 (0.00%)  0 1/53 (1.89%)  1
Immune system disorders     
ALLERGIC RHINITIS *  0/57 (0.00%)  0 1/53 (1.89%)  1
FACIAL SWELLING OF ALLERGIC ORIGIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
Infections and infestations     
INFECTED SEBACEOUS CYST R. AXILA *  1/57 (1.75%)  1 0/53 (0.00%)  0
PNEUMONIA *  0/57 (0.00%)  0 1/53 (1.89%)  1
VAGINAL YEAST INFECTION *  0/57 (0.00%)  0 1/53 (1.89%)  1
VIRAL INFECTION INCLUDING COUGHING *  1/57 (1.75%)  1 0/53 (0.00%)  0
Investigations     
ELEVATED CREATININE *  1/57 (1.75%)  1 0/53 (0.00%)  0
ELEVATED INR *  1/57 (1.75%)  1 0/53 (0.00%)  0
VITAMIN D DEFICIENCY *  0/57 (0.00%)  0 1/53 (1.89%)  1
WEIGHT GAIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
Metabolism and nutrition disorders     
HUNGRIER *  0/57 (0.00%)  0 1/53 (1.89%)  2
HYPOKALEMIA *  1/57 (1.75%)  1 0/53 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRITIS PAIN, KNEES *  0/57 (0.00%)  0 1/53 (1.89%)  1
ARTHRITIS PAIN, LOWER BACK *  0/57 (0.00%)  0 1/53 (1.89%)  1
BROKEN TOOTH-UNCOMPLICATED *  0/57 (0.00%)  0 1/53 (1.89%)  1
DISLOCATION OF LEFT SHOULDER *  0/57 (0.00%)  0 1/53 (1.89%)  1
FALL, HIP AND BACK PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
FEET AND LEGS CRAMPS *  1/57 (1.75%)  1 0/53 (0.00%)  0
FRACTURE 5TH R METACARPAL *  1/57 (1.75%)  1 0/53 (0.00%)  0
JOINT PAIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
KNEE PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
LEFT LEG VASCULAR CLAUDICATION *  0/57 (0.00%)  0 1/53 (1.89%)  2
LEFT SIDE PAIN *  0/57 (0.00%)  0 2/53 (3.77%)  2
LEG CRAMPS *  1/57 (1.75%)  1 2/53 (3.77%)  2
LOWER BACK PAIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
LOWER BACK SURGERY *  1/57 (1.75%)  1 0/53 (0.00%)  0
LOWER BACKACHE *  1/57 (1.75%)  1 0/53 (0.00%)  0
LOWER EXTREMITY EDEMA *  0/57 (0.00%)  0 2/53 (3.77%)  2
MUSCLE CRAMPS *  1/57 (1.75%)  1 1/53 (1.89%)  1
MUSCLE CRAMPS OF BOTH LEGS *  0/57 (0.00%)  0 1/53 (1.89%)  1
MUSCLE MOVEMENT *  0/57 (0.00%)  0 1/53 (1.89%)  1
MUSCULOSKELETAL PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
MUSCULOSKELETAL PAIN (NECK) *  0/57 (0.00%)  0 1/53 (1.89%)  1
MYALGIA *  1/57 (1.75%)  1 0/53 (0.00%)  0
NECK PAIN *  1/57 (1.75%)  1 1/53 (1.89%)  1
OLECRANON BURSITIS *  1/57 (1.75%)  1 0/53 (0.00%)  0
PAIN IN BOTH HANDS AND FEET *  0/57 (0.00%)  0 1/53 (1.89%)  1
PAIN IN KNEE *  0/57 (0.00%)  0 1/53 (1.89%)  1
PAIN LEFT SIDE OF CHEST *  0/57 (0.00%)  0 1/53 (1.89%)  1
PAIN ON ANKLE JOINTS *  0/57 (0.00%)  0 1/53 (1.89%)  1
PAIN ON HIP *  0/57 (0.00%)  0 1/53 (1.89%)  1
PAIN ON KNEE *  0/57 (0.00%)  0 1/53 (1.89%)  1
SPRAINED ANKLE *  0/57 (0.00%)  0 1/53 (1.89%)  1
STIFF NECK *  0/57 (0.00%)  0 1/53 (1.89%)  1
STIFFNESS OF JOINTS *  0/57 (0.00%)  0 1/53 (1.89%)  1
WEAKNESS *  1/57 (1.75%)  1 0/53 (0.00%)  0
WORSENING OF BACK PAIN *  1/57 (1.75%)  1 0/53 (0.00%)  0
Nervous system disorders     
BLACK OUT *  0/57 (0.00%)  0 1/53 (1.89%)  1
DIZZINESS *  5/57 (8.77%)  6 4/53 (7.55%)  6
FORGETFULNESS *  0/57 (0.00%)  0 1/53 (1.89%)  1
HEADACHE *  13/57 (22.81%)  16 11/53 (20.75%)  13
HEADACHE-SINUS *  0/57 (0.00%)  0 1/53 (1.89%)  1
HEPATIC ENCEPHALOPATHY *  0/57 (0.00%)  0 1/53 (1.89%)  1
INTERMITTENT HEADACHE *  1/57 (1.75%)  1 1/53 (1.89%)  1
INVOLUNTARY MOVEMENT *  1/57 (1.75%)  1 1/53 (1.89%)  1
MEMORY LOSS *  0/57 (0.00%)  0 1/53 (1.89%)  1
PINCHED NERVE *  0/57 (0.00%)  0 1/53 (1.89%)  1
TICS *  0/57 (0.00%)  0 1/53 (1.89%)  1
Psychiatric disorders     
ANXIETY *  3/57 (5.26%)  3 0/53 (0.00%)  0
DECREASED INSOMNIA *  1/57 (1.75%)  1 0/53 (0.00%)  0
DEPRESSION *  1/57 (1.75%)  1 1/53 (1.89%)  1
HAPPIER *  0/57 (0.00%)  0 1/53 (1.89%)  1
HYPERSOMNIA *  2/57 (3.51%)  2 0/53 (0.00%)  0
INSOMNIA *  9/57 (15.79%)  11 8/53 (15.09%)  9
IRRITABILITY *  0/57 (0.00%)  0 1/53 (1.89%)  1
MANIA *  1/57 (1.75%)  1 2/53 (3.77%)  5
MOOD ALTERATION *  2/57 (3.51%)  7 2/53 (3.77%)  2
MOOD ALTERATION DEPRESSION *  1/57 (1.75%)  2 0/53 (0.00%)  0
MOOD ALTERATION-ANXIETY *  1/57 (1.75%)  1 0/53 (0.00%)  0
MOOD ALTERATION-HAPPY *  1/57 (1.75%)  1 0/53 (0.00%)  0
MOOD ALTERATION:ANXIETY *  0/57 (0.00%)  0 1/53 (1.89%)  1
RESTLESSNESS *  0/57 (0.00%)  0 1/53 (1.89%)  1
VIVID DREAMS *  0/57 (0.00%)  0 1/53 (1.89%)  1
WORSENING OF ANXIETY *  1/57 (1.75%)  1 0/53 (0.00%)  0
Renal and urinary disorders     
DARK COLORED URINE *  0/57 (0.00%)  0 1/53 (1.89%)  1
ELEVATED AFP *  0/57 (0.00%)  0 1/53 (1.89%)  1
INCREASE PEE *  0/57 (0.00%)  0 1/53 (1.89%)  1
INCREASED URINATION *  12/57 (21.05%)  13 9/53 (16.98%)  10
URINE ODOR *  0/57 (0.00%)  0 1/53 (1.89%)  1
Reproductive system and breast disorders     
BREAST TENDERNESS *  1/57 (1.75%)  1 0/53 (0.00%)  0
VAGINAL IRRITATION *  1/57 (1.75%)  1 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
BLEEDING ESPHAGEAL VARICES *  0/57 (0.00%)  0 1/53 (1.89%)  1
BLOOD IN STOOLS *  1/57 (1.75%)  1 0/53 (0.00%)  0
BRONCHITIS *  0/57 (0.00%)  0 1/53 (1.89%)  1
CHEST CONGESTION *  0/57 (0.00%)  0 1/53 (1.89%)  1
COUGH *  3/57 (5.26%)  3 0/53 (0.00%)  0
NOSE BLEEDING *  0/57 (0.00%)  0 1/53 (1.89%)  1
RESPIRATORY TRACT INFECTION *  0/57 (0.00%)  0 1/53 (1.89%)  1
SHORTNESS OF BREATH *  1/57 (1.75%)  1 0/53 (0.00%)  0
SINUS PAIN *  0/57 (0.00%)  0 1/53 (1.89%)  1
SINUSITIS *  1/57 (1.75%)  1 0/53 (0.00%)  0
Skin and subcutaneous tissue disorders     
ANAL IRRITATION *  1/57 (1.75%)  1 0/53 (0.00%)  0
BRUISING R LEG *  0/57 (0.00%)  0 1/53 (1.89%)  1
CELLULITIS *  0/57 (0.00%)  0 2/53 (3.77%)  2
CYST ON PATELLA *  1/57 (1.75%)  1 0/53 (0.00%)  0
HAIR LOSS *  0/57 (0.00%)  0 1/53 (1.89%)  1
INCREASED SWEATING *  1/57 (1.75%)  1 0/53 (0.00%)  0
ITCHINESS ALL OVER THE BODY *  1/57 (1.75%)  1 1/53 (1.89%)  1
ITCHING *  1/57 (1.75%)  1 1/53 (1.89%)  1
MACULOPAPULAR RASH ON TORSO *  1/57 (1.75%)  1 0/53 (0.00%)  0
MILD RASH *  1/57 (1.75%)  1 0/53 (0.00%)  0
RASH *  1/57 (1.75%)  1 2/53 (3.77%)  2
RASH ON BOTH ARMS *  0/57 (0.00%)  0 1/53 (1.89%)  1
RASH ON EXTREMETIES *  0/57 (0.00%)  0 1/53 (1.89%)  1
SKIN RASH *  0/57 (0.00%)  0 1/53 (1.89%)  2
SWEATING *  5/57 (8.77%)  5 6/53 (11.32%)  9
SWEATING "NIGHT" *  1/57 (1.75%)  1 0/53 (0.00%)  0
ULCERATION OF THE LIP *  1/57 (1.75%)  1 0/53 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Timothy R. Morgan
Organization: University of California, Irvine
Phone: 562-826-5756
Responsible Party: Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00513461     History of Changes
Other Study ID Numbers: UCI 06-07 / NCI-2009-00897
N01CN35160 ( U.S. NIH Grant/Contract )
CDR0000558657 ( Registry Identifier: PDQ (Physician Data Query) )
UCI04-3-01 ( Other Grant/Funding Number: NCI )
First Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: August 24, 2017
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018