Trial Outcomes & Findings for Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer (NCT NCT00402285)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

baseline through 3 month

Results posted on

2016-01-01

Participant Flow

Potentially eligible men identified at Urologic Oncology clinic at Helen Diller Family Comprehensive Cancer Center San Francisco starting in 2003.

Participant milestones

Participant milestones
Measure	Lycopene Supplement two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene \& placebo for fish oil.	Fish Oil Supplement three 1g fish oil capsules daily including 1,098mg EPA \& 549mg DHA fatty acid (Roche). men took fish oil \& placebo for lycopene.	Placebo men took placebo for lycopene \& placebo for fish oil.
Overall Study STARTED	29	27	28
Overall Study COMPLETED	22	21	26
Overall Study NOT COMPLETED	7	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lycopene Supplement two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene \& placebo for fish oil.	Fish Oil Supplement three 1g fish oil capsules daily including 1,098mg EPA \& 549mg DHA fatty acid (Roche). men took fish oil \& placebo for lycopene.	Placebo men took placebo for lycopene \& placebo for fish oil.
Overall Study insufficient RNA quality	7	6	2

Baseline Characteristics

Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lycopene Supplement n=29 Participants two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene \& placebo for fish oil.	Fish Oil Supplement n=27 Participants three 1g fish oil capsules daily including 1,098mg EPA \& 549mg DHA fatty acid (Roche). men took fish oil \& placebo for lycopene.	Placebo n=28 Participants men took placebo for lycopene \& placebo for fish oil.	Total n=84 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 7 • n=5 Participants	62 years STANDARD_DEVIATION 8 • n=7 Participants	59 years STANDARD_DEVIATION 8 • n=5 Participants	61 years STANDARD_DEVIATION 8 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline through 3 month

Population: 1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.

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.

Outcome measures

Outcome measures
Measure	Lycopene Supplement n=22 Participants two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene \& placebo for fish oil.	Fish Oil Supplement n=20 Participants three 1g fish oil capsules daily including 1,098mg EPA \& 549mg DHA fatty acid (Roche). men took fish oil \& placebo for lycopene.	Placebo n=26 Participants men took placebo for lycopene \& placebo for fish oil.
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 IGF-1	0.05 fold change Standard Deviation 1.32	NA fold change Standard Deviation NA we did not measure IGF for fish oil	0.02 fold change Standard Deviation 1.22
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 COX-2	NA fold change Standard Deviation NA we did not measure COX-2 for lycopene	0.39 fold change Standard Deviation 1.98	0.40 fold change Standard Deviation 2.19
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 IGF-1R	0.20 fold change Standard Deviation 3.00	NA fold change Standard Deviation NA we did not measure IGF for fish oil	0.74 fold change Standard Deviation 2.86

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Carroll, MD

University of California, San Francisco

Phone: 415-353-7098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place