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Trial record 8 of 29 for:    GUSB

Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II 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: NCT00402285
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : May 16, 2013
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Dietary Supplement: lycopene supplement
Dietary Supplement: fish oil supplement
Other: Placebo
Enrollment 84
Recruitment Details Potentially eligible men identified at Urologic Oncology clinic at Helen Diller Family Comprehensive Cancer Center San Francisco starting in 2003.
Pre-assignment Details  
Arm/Group Title Lycopene Supplement Fish Oil Supplement Placebo
Hide Arm/Group Description two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.

three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).

men took fish oil & placebo for lycopene.

men took placebo for lycopene & placebo for fish oil.
Period Title: Overall Study
Started 29 27 28
Completed 22 21 26
Not Completed 7 6 2
Reason Not Completed
insufficient RNA quality             7             6             2
Arm/Group Title Lycopene Supplement Fish Oil Supplement Placebo Total
Hide Arm/Group Description two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.

three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).

men took fish oil & placebo for lycopene.

men took placebo for lycopene & placebo for fish oil. Total of all reporting groups
Overall Number of Baseline Participants 29 27 28 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 27 participants 28 participants 84 participants
61  (7) 62  (8) 59  (8) 61  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 28 participants 84 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
29
 100.0%
27
 100.0%
28
 100.0%
84
 100.0%
1.Primary Outcome
Title Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2
Hide Description Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.
Time Frame baseline through 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.
Arm/Group Title Lycopene Supplement Fish Oil Supplement Placebo
Hide Arm/Group Description:
two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.

three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).

men took fish oil & placebo for lycopene.

men took placebo for lycopene & placebo for fish oil.
Overall Number of Participants Analyzed 22 20 26
Mean (Standard Deviation)
Unit of Measure: fold change
IGF-1 0.05  (1.32) NA [1]   (NA) 0.02  (1.22)
COX-2 NA [2]   (NA) 0.39  (1.98) 0.40  (2.19)
IGF-1R 0.20  (3.00) NA [1]   (NA) 0.74  (2.86)
[1]
we did not measure IGF for fish oil
[2]
we did not measure COX-2 for lycopene
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/84 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/84 (0.00%) 
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: Peter Carroll, MD
Organization: University of California, San Francisco
Phone: 415-353-7098
EMail: pcarroll@urology.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00402285     History of Changes
Other Study ID Numbers: CDR0000505501
UCSF-03553
UCSF-H5664-22834-04A
First Submitted: November 20, 2006
First Posted: November 22, 2006
Results First Submitted: September 13, 2012
Results First Posted: May 16, 2013
Last Update Posted: January 1, 2016