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Trial record 30 of 86 for:    catechin

Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer

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: NCT00253643
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : February 18, 2015
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jackie Shannon, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Precancerous Condition
Prostate Cancer
Interventions Dietary Supplement: green tea catechin extract
Dietary Supplement: fish oil
Other: placebo
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo)
Hide Arm/Group Description

Patients receive oral fish oil 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

fish oil: Given orally 3 times/day

laboratory biomarker analysis: Correlative studies

questionnaire administration: Ancillary studies

Patients receive an oil placebo 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

placebo: Given olive oil placebo orally 3 times/day

laboratory biomarker analysis: Correlative studies

questionnaire administration: Ancillary studies

Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day

fish oil: Given orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

laboratory biomarker analysis: Correlative studies

questionnaire administration: Ancillary studies

Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day

placebo: Given olive oil placebo orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

laboratory biomarker analysis: Correlative studies

questionnaire administration: Ancillary studies

Period Title: Overall Study
Started 14 15 29 31
Completed 14 15 28 28
Not Completed 0 0 1 3
Reason Not Completed
Withdrawal by Subject             0             0             1             1
Non-Compliance             0             0             0             2
Arm/Group Title Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo) Total
Hide Arm/Group Description

Patients receive oral fish oil 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

fish oil: Given orally 3 times/day

Patients receive an oil placebo 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

placebo: Given olive oil placebo orally 3 times/day

Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day

fish oil: Given orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day

placebo: Given olive oil placebo orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

Total of all reporting groups
Overall Number of Baseline Participants 14 15 28 28 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 28 participants 28 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  57.1%
10
  66.7%
18
  64.3%
19
  67.9%
55
  64.7%
>=65 years
6
  42.9%
5
  33.3%
10
  35.7%
9
  32.1%
30
  35.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 28 participants 28 participants 85 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
15
 100.0%
28
 100.0%
28
 100.0%
85
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 28 participants 28 participants 85 participants
14 15 28 28 85
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 28 participants 28 participants 85 participants
Benign 9 11 16 21 57
Prostate Cancer 2 1 6 6 15
Prostatic Intraepithelial Neoplasia (PIN) 3 3 6 1 13
1.Primary Outcome
Title Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
Hide Description Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.
Time Frame Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:
Fish oil, Green Tea catechin extract
Fish oil placebo, Green Tea catechin extract
Fish oil, Green Tea placebo
Fish oil placebo, Green Tea placebo
Overall Number of Participants Analyzed 14 15 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
PRE data 147  (98.6) 158.8  (84.6) 138.3  (63.8) 102.3  (85.9)
POST data 140.7  (100.3) 159.3  (75.5) 145.2  (72.2) 152.2  (80.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1521
Comments Utilized a priori threshold for statistical significance of 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
Hide Description Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.
Time Frame End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:
Fish oil, Green Tea catechin extract
Fish oil placebo, Green Tea catechin extract
Fish oil, Green Tea placebo
Fish oil placebo, Green Tea placebo
Overall Number of Participants Analyzed 14 15 28 28
Median (Full Range)
Unit of Measure: %age of cells & nuclei stained
18.5
(1 to 55)
8
(2 to 52)
10
(0 to 45)
12
(1 to 50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1573
Comments A priori threshold for statistical significance is 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse event data were collected every month the subject was on study via questionnaire over the phone. We conducted a 30-day follow-up phone call and utilized our adverse event questionnaire to capture this information at baseline as well.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo)
Hide Arm/Group Description

Patients receive oral fish oil 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

fish oil: Given orally 3 times/day

Patients receive an oil placebo 3/day and oral green tea extract 2/day

green tea catechin extract: Given orally 2 times/day

placebo: Given olive oil placebo orally 3 times/day

Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day

fish oil: Given orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day

placebo: Given olive oil placebo orally 3 times/day

placebo: Given green tea placebo orally 2 times/day

All-Cause Mortality
Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%)   0/29 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Fish Oil, Green Tea Catechin Extract) Arm II (Fish Oil Placebo, Green Tea Catechin Extract) Arm III (Fish Oil, Green Tea Placebo) Arm IV (Fish Oil Placebo, Green Tea Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   2/15 (13.33%)   5/29 (17.24%)   1/31 (3.23%) 
Gastrointestinal disorders         
Bloating (grade 2)  1  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Gas/Flatulence (grade 2)  1  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  0/31 (0.00%) 
Burping (grade 2)  1  0/14 (0.00%)  1/15 (6.67%)  0/29 (0.00%)  1/31 (3.23%) 
Nausea/Vomiting (grade 2)  1  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  0/31 (0.00%) 
Upset Stomach (grade 2)  1  0/14 (0.00%)  0/15 (0.00%)  1/29 (3.45%)  1/31 (3.23%) 
Diarrhea/ Loose Stool (grade 2)  1  0/14 (0.00%)  0/15 (0.00%)  1/29 (3.45%)  0/31 (0.00%) 
Heartburn (grade 2)  1  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders         
Muscle Pain (grade 2)  1  1/14 (7.14%)  1/15 (6.67%)  0/29 (0.00%)  1/31 (3.23%) 
Nervous system disorders         
Headache (grade 2)  1  0/14 (0.00%)  0/15 (0.00%)  2/29 (6.90%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders         
Bruising (grade 2)  1  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jackilen Shannon
Organization: Oregon Health & Science University
Phone: 503-220-8262 ext 54868
EMail: shannoja@ohsu.edu
Layout table for additonal information
Responsible Party: Jackie Shannon, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00253643     History of Changes
Other Study ID Numbers: CDR0000443617
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-CI-CPC-04131-LX ( Other Identifier: OHSU Knight Cancer Institute number )
VAMC-04-0303/ M1016 ( Other Identifier: Portland VA IRB number )
DOD-W81XWH-04-1-0296 ( Other Grant/Funding Number: Dept of Defense Award Number )
OHSU-1117 ( Other Identifier: OHSU IRB number )
KPNW-NW-05SLIEB-01 ( Other Identifier: Kaiser Permanente NW IRB number )
First Submitted: November 11, 2005
First Posted: November 15, 2005
Results First Submitted: December 19, 2014
Results First Posted: February 18, 2015
Last Update Posted: April 18, 2017