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Trial record 67 of 80 for:    "curcumin" and "cancer"

Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)

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ClinicalTrials.gov Identifier: NCT00365209
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Healthy, no Evidence of Disease
Tobacco Use Disorder
Interventions Other: laboratory biomarker analysis
Other: pharmacological study
Drug: curcumin
Enrollment 44
Recruitment Details  
Pre-assignment Details This is a 2-stage study. In Stage1, there are 23 enrolled participants who received 2 g curcumin. In Stage2, there are addictional 21 enrolled participants who received 4 g curcumin.
Arm/Group Title Curcumin
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Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Period Title: Stage 1: Receiving 2g Curcumin
Started 23
Completed 21
Not Completed 2
Period Title: Stage 2: Receiving 4g Curcumin
Started 21
Completed 19
Not Completed 2
Arm/Group Title Curcumin
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Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
Stage 1: 2g curcumin (N = 22 participants due to 1 participant withdrew consent after start of treatment) Stage 2: 4g curcumin (N = 21 participants)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
Stage1 2 g (curcumin) N=22 57.1  (5.0)
Stage2 4 g (curcumin) N=21 52.2  (6.8)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Stage1 2 g (curcumin): Female 13
Stage1 2 g (curcumin): Male 9
Stage2 4 g (curcumin): Female 12
Stage2 4 g (curcumin): Male 9
1.Primary Outcome
Title Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Hide Description Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
Time Frame Baseline
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Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants) and Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
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Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 1.1  (1.8)
Stage2 4 g (curcumin) N=19 3.4  (4.8)
2.Primary Outcome
Title Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Hide Description Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 1.6  (1.8)
Stage2 4 g (curcumin) N=19 3.7  (3.2)
3.Secondary Outcome
Title Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Hide Description Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 1.4  (0.9)
Stage2 4 g (curcumin) N=19 2.3  (1.6)
4.Secondary Outcome
Title Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Hide Description Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue
Time Frame At 30 Day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 1.4  (1.0)
Stage2 4 g (curcumin) N=19 1.9  (0.9)
5.Secondary Outcome
Title Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Hide Description Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 2.1  (3.2)
Stage2 4 g (curcumin) N=19 2.7  (1.9)
6.Secondary Outcome
Title Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Hide Description Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 2.7  (3.7)
Stage2 4 g (curcumin) N=19 2.6  (2.9)
7.Secondary Outcome
Title Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Hide Description Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 2.3  (1.3)
Stage2 4 g (curcumin) N=19 2.5  (1.5)
8.Secondary Outcome
Title Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Hide Description Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: µg/g protein
Stage1 2 g (curcumin) N=21 2.4  (1.2)
Stage2 4 g (curcumin) N=19 2.2  (1.6)
9.Secondary Outcome
Title Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance
Hide Description The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson’s correlation coefficient or Spearman’s rank order correlation coefficient.
Time Frame Baseline to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
There is not enough tissue for the analysis, so no data is provided.
Arm/Group Title Curcumin
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Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Changes in Total Aberrant Crypt Foci (ACF) Number
Hide Description Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment
Time Frame Baseline to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: Number of ACF
Stage1 2 g (curcumin) N=22
0.0
(-18 to 15)
Stage2 4 g (curcumin) N=19
6.0
(-1 to 14)
11.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 0.5  (0.9)
Stage2 4 g (curcumin) N=17 0.3  (0.6)
12.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Hide Description [Not Specified]
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g crucumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 0.6  (1.4)
Stage 2 4 g (curcumin) N=19 0.3  (0.8)
13.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin : (N = 17 participants).
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 11.9  (4.2)
Stage2 4 g (curcumin) N=17 12.8  (6.1)
14.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Hide Description [Not Specified]
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 11.8  (7.2)
Stage2 4 g (curcumin) N=19 16.4  (10.3)
15.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 25.2  (5.3)
Stage2 4 g (curcumin) N=17 28.7  (9.1)
16.Secondary Outcome
Title Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Hide Description [Not Specified]
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: percentage of labeled cells
Stage1 2 g (curcumin) N=22 23.5  (8.0)
Stage2 4 g (curcumin) N=19 30.9  (7.7)
17.Secondary Outcome
Title Baseline Curcumin Concentration in Rectal Mucosa
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 21 participants in the 2g curcumin arm and 18 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin in rectal mucosa were found in 1 participant in the 2g arm and none in participants on the 4g arm. Therefore, only 1 sample from the 2g arm and 0 samples from the 4g arm are reported here.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 1
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
1
Mean (Standard Deviation)
Unit of Measure: µg/g protein
4.03
18.Secondary Outcome
Title Post-treatment Curcumin Concentration in Rectal Mucosa
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on 39 participants (21 participants from 2g curcmin, and 18 participants from 4 g curcumin). In 2g group, a total of 5 samples with detectable levels were analyzed. In 4g group, a total of 3 samples with detectable levels were analyzed.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 39
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
8
Mean (Standard Deviation)
Unit of Measure: µg/g protein
2 g (curcumin) N=21 subjects, N=5 samples analyzed 8.2  (2.9)
4 g (curcumin) N=18 subjects, N=3 samples analyzed 3.8  (0.6)
19.Secondary Outcome
Title Baseline Curcumin Plasma Concentrations
Hide Description Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 4 participants in the 4g arm; therefore, 4 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
4
Mean (Standard Deviation)
Unit of Measure: µg/mL
7.3  (8.1)
20.Secondary Outcome
Title Post-treatment Curcumin Plasma Concentrations
Hide Description Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 2 participants in the 4g arm; therefore, 2 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
2
Mean (Standard Deviation)
Unit of Measure: µg/mL
3.8  (1.3)
21.Secondary Outcome
Title Baseline Curcumin Conjugates Concentration in Rectal Mucosa
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 21 participants in the 2g curcumin arm and 19 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin conjugates in rectal mucosa were found in 0 participants in the 2g arm and 1 participant on the 4g arm. Therefore, 0 samples from the 2g arm and 1 sample from the 4g arm are reported here.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 1
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
1
Mean (Standard Deviation)
Unit of Measure: µg/g protein
4.21
22.Secondary Outcome
Title Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on 39 participants (21 participants from 2g curcumin group and 18 participatns from 4g curcumin group). In 2g group, a total of 13 samples with detectable levels were analyzed. In 4g group, a total of 12 samples with detectable levels were analyzed.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 39
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
25
Mean (Standard Deviation)
Unit of Measure: µg/g protein
2 g (curcumin) N=21 subjects, N=13 samples 5.9  (2.6)
4 g (curcumin) N=18 subjects, N=12 samples 4.5  (1.7)
23.Secondary Outcome
Title Baseline Curcumin Conjugates Plasma Concentrations
Hide Description Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
19
Mean (Standard Deviation)
Unit of Measure: µg/mL
15.8  (14.8)
24.Secondary Outcome
Title Post-treatment Curcumin Conjugates Plasma Concentrations
Hide Description Post-treatment curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Time Frame At 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.
Arm/Group Title Curcumin
Hide Arm/Group Description:

Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Samples with detectable levels
19
Mean (Standard Deviation)
Unit of Measure: µg/mL
78.5  (84.3)
25.Secondary Outcome
Title Number of Participants at Each Adverse Event Grade Level
Hide Description [Not Specified]
Time Frame Baseline to 30 days
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Hide Analysis Population Description
These participants completed the study. The data is from the final dataset which was available in 2013 following the publication.
Arm/Group Title Curcumin
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Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
2 g (curcumin) N=22: No AE reported 10
2 g (curcumin) N=22: AE with a grade of 1 or 2 12
2 g (curcumin) N=22: AE with a grade of 3 0
4 g (curcumin) N=19: No AE reported 8
4 g (curcumin) N=19: AE with a grade of 1 or 2 10
4 g (curcumin) N=19: AE with a grade of 3 1
Time Frame All adverse events are reported and documented from 43 treated participants from the final 2013 dataset. Participants were followed for the duration of the study, an average of 45 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stage1 2 g Curcumin Stage2 4 g Curcumin
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Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally

All-Cause Mortality
Stage1 2 g Curcumin Stage2 4 g Curcumin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stage1 2 g Curcumin Stage2 4 g Curcumin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      1/21 (4.76%)    
General disorders     
ATYPICAL CHEST PAIN *  0/22 (0.00%)  0 1/21 (4.76%)  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%
Stage1 2 g Curcumin Stage2 4 g Curcumin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/22 (54.55%)      11/21 (52.38%)    
Eye disorders     
EYE VISION IS BLURRY *  0/22 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders     
YELLOW, SOFTER POO *  1/22 (4.55%)  1 0/21 (0.00%)  0
ABDOMINAL CRAMPING *  1/22 (4.55%)  1 0/21 (0.00%)  0
ABDOMINAL DISCOMFORT *  0/22 (0.00%)  0 1/21 (4.76%)  1
CALMED MY STOMACH *  1/22 (4.55%)  1 0/21 (0.00%)  0
CONSTIPATION *  1/22 (4.55%)  1 0/21 (0.00%)  0
CURBED APPETITE *  1/22 (4.55%)  1 0/21 (0.00%)  0
DIARRHEA *  2/22 (9.09%)  2 0/21 (0.00%)  0
FULLNESS *  1/22 (4.55%)  1 0/21 (0.00%)  0
GAS *  1/22 (4.55%)  1 0/21 (0.00%)  0
HELPED BOWEL MOVEMENTS, MORE FREQUENT, LOOSER *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED, EASIER BOWEL MOVEMENTS *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED, SOFTER STOOL *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED; CURCUMIN HELPED CONSTIPATION; BEFORE GOING EVERY 3-4 DAYS, NOW EVERY 2 DAYS *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED; CURCUMIN WAS BETTER FOR BOWEL MOVEMENT, SOFTER STOOL *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED; MORE FREQUENT BOWEL MOVEMENTS *  1/22 (4.55%)  1 0/21 (0.00%)  0
IMPROVED; NO LONGER CONSTIPATED, CONSTIPATION BEGAN IN 2006; NOW MORE FREQUENT BOWEL MOVEMENTS *  0/22 (0.00%)  0 1/21 (4.76%)  1
IMPROVED; NOT TOO MUCH GAS IN THE STOMACH *  0/22 (0.00%)  0 1/21 (4.76%)  1
LITTLE BLOATED *  0/22 (0.00%)  0 1/21 (4.76%)  1
LITTLE BURNING IN STOMACH *  0/22 (0.00%)  0 1/21 (4.76%)  1
LITTLE GAS *  1/22 (4.55%)  1 0/21 (0.00%)  0
MILD HEART BURN *  1/22 (4.55%)  1 0/21 (0.00%)  0
NAUSEA *  0/22 (0.00%)  0 1/21 (4.76%)  1
NO MORE CONSTIPATION, PILL REALLY HELPED *  0/22 (0.00%)  0 1/21 (4.76%)  1
SIDE HURTS *  1/22 (4.55%)  1 0/21 (0.00%)  0
STOMACH UPSET AND RELATED PAINS *  1/22 (4.55%)  1 0/21 (0.00%)  0
VOMITTED AFTER TAKING PILLS *  1/22 (4.55%)  1 0/21 (0.00%)  0
YELLOW STOOL *  1/22 (4.55%)  1 2/21 (9.52%)  2
General disorders     
BEGINNING OF INFLUENZA *  1/22 (4.55%)  1 0/21 (0.00%)  0
Investigations     
ELEVATED CREATININE *  1/22 (4.55%)  1 0/21 (0.00%)  0
Metabolism and nutrition disorders     
DECREASED APPETITE *  1/22 (4.55%)  1 0/21 (0.00%)  0
LOSS OF APPETITE *  0/22 (0.00%)  0 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders     
IMPROVED; LESS ACHEY *  1/22 (4.55%)  1 0/21 (0.00%)  0
LEFT AND RIGHT LEG LOWER EDEMA *  1/22 (4.55%)  1 0/21 (0.00%)  0
LOWER BACK PAIN *  1/22 (4.55%)  1 0/21 (0.00%)  0
STIFFNESS IN NECK *  0/22 (0.00%)  0 1/21 (4.76%)  1
STRAINED SORE CHEST MUSCLES *  1/22 (4.55%)  1 0/21 (0.00%)  0
Nervous system disorders     
HEADACHE *  1/22 (4.55%)  1 0/21 (0.00%)  0
HEADACHE AT NIGHT *  0/22 (0.00%)  0 1/21 (4.76%)  1
PEPPER TASTE *  1/22 (4.55%)  1 0/21 (0.00%)  0
Psychiatric disorders     
UNUSUAL DREAM STATE *  1/22 (4.55%)  1 0/21 (0.00%)  0
WEIRD DREAMS *  1/22 (4.55%)  1 0/21 (0.00%)  0
Renal and urinary disorders     
BURNING WHEN PEE *  1/22 (4.55%)  1 0/21 (0.00%)  0
PEEING A LOT *  0/22 (0.00%)  0 1/21 (4.76%)  1
SLOW URINATION *  1/22 (4.55%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COLD/SINUSES *  0/22 (0.00%)  0 1/21 (4.76%)  1
SORE THROAT *  1/22 (4.55%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
ITCHING *  1/22 (4.55%)  1 0/21 (0.00%)  0
ITCHING ALL OVER *  0/22 (0.00%)  0 1/21 (4.76%)  1
*
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
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Name/Title: Dr. Frank L. Meyskens, Jr.
Organization: University of California, Irvine
Phone: 714-456-6310
EMail: flmeyske@uci.edu
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00365209     History of Changes
Other Study ID Numbers: NCI-2013-00449
NCI-2013-00449 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UIC-2005-0617
CDR0000483003
UCIRVINE-2005-4586
UIC HS# 2005-0617
CCUM-HUM00000731
P30CA062203 ( U.S. NIH Grant/Contract )
2005-0617 ( Other Identifier: Chao Family Comprehensive Cancer Center )
UCI04-2-01 ( Other Identifier: DCP )
N01CN35160 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: April 18, 2014
Results First Posted: August 27, 2015
Last Update Posted: August 27, 2015