Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
OHSU Knight Cancer Institute
Collaborators:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00253643
First received: November 11, 2005
Last updated: December 7, 2012
Last verified: December 2012
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Purpose
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer.
PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.
| Condition | Intervention |
|---|---|
|
Precancerous Condition Prostate Cancer |
Dietary Supplement: defined green tea catechin extract Dietary Supplement: omega-3 fatty acid Other: placebo Other: laboratory biomarker analysis Other: questionnaire administration |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Fatty acid synthase expression by immunohistochemistry at pre- and post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Cell proliferation by Ki67-immunohistochemistry at pre- and post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Phospholipid membrane composition by sucrose gradient ultracentrifugation at post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Comparison of the synergistic effect of combined green tea and fish oil to placebo or green tea supplementation alone [ Time Frame: End of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sterol regulatory element binding protein expression by immunohistochemistry at pre- and post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Apoptosis as measured by TUNEL at pre- and post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Bone formation and loss by serum and urine osteocalcin and N-telopeptides at pre- and post-intervention [ Time Frame: End of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (fish oil, green tea extract)
Patients receive oral fish oil three times daily and oral green tea extract twice daily.
|
Dietary Supplement: defined green tea catechin extract
Given orally
Other Name: Polyphenon E
Dietary Supplement: omega-3 fatty acid
Given orally
Other Name: fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
|
|
Experimental: Arm II (fish oil placebo, green tea extract)
Patients receive an oil placebo three times daily and oral green tea extract twice daily.
|
Dietary Supplement: defined green tea catechin extract
Given orally
Other Name: Polyphenon E
Other: placebo
Given fish oil placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
|
|
Experimental: Arm III (fish oil, green tea extract placebo)
Patients receive oral fish oil three times daily and a placebo twice daily
|
Dietary Supplement: omega-3 fatty acid
Given orally
Other Name: fish oil, n-3 fatty acid, O3FA, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Other: placebo
Given green tea extract placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
|
|
Placebo Comparator: Arm IV (fish oil placebo, green tea extract placebo)
Patients receive an oil placebo three times daily and another placebo twice daily.
|
Other: placebo
Given fish oil placebo orally
Other Name: PLCB
Other: placebo
Given green tea extract placebo orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
|
Detailed Description:
OBJECTIVES:
- Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily.
- Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily.
- Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
- Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily.
Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity.
All patients undergo a prostate biopsy on the last day of study treatment.
After completion of study treatment, patients receive a follow-up phone call at/around 30 days later.
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
INCLUSION CRITERIA:
- Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)
EXCLUSION CRITERIA:
- Definitive invasive prostate cancer on initial biopsy
- Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
- History of ventricular tachycardia or ventricular fibrillation
- Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
- Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
- Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.
- Subject reported allergy or sensitivity to fish oil, olive oil or green tea
- Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
- Total bilirubin greater than institutional upper limit of normal
- Concurrent high risk study participation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253643
Locations
| United States, Oregon | |
| Kaiser Permanente Center for Health Research | |
| Portland, Oregon, United States, 97227 | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Jackilen Shannon, PhD | OHSU Knight Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00253643 History of Changes |
| Other Study ID Numbers: | CDR0000443617, P30CA069533, OHSU-CI-CPC-04131-LX, VAMC-04-0303/ M1016, DOD-W81XWH-04-1-0296, OHSU-1117, KPNW-NW-05SLIEB-01 |
| Study First Received: | November 11, 2005 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by OHSU Knight Cancer Institute:
|
prostate cancer precancerous condition |
Additional relevant MeSH terms:
|
Precancerous Conditions Prostatic Neoplasms Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Epigallocatechin gallate Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013