Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer
Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle
RATIONALE: Learning about changes in DNA over time in patients with prostate cancer undergoing diet and lifestyle changes may help doctors learn about the long-term effects of these changes on disease progression.
PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with previously untreated stage I or stage II prostate cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- To measure changes in gene expression in prostate tissue core biopsy samples before and after a low-fat diet and lifestyle intervention in patients with previously untreated stage I or II adenocarcinoma of the prostate.
- To collect health information from these patients to enable better understanding of the long term impact of diet and lifestyle changes on prostate cancer progression.
OUTLINE:
- Intervention phase: Patients are placed on a comprehensive lifestyle change program comprising a low-fat vegan diet, stress management, moderate aerobic exercise, and regular participation in a support group for 3 months.
- Follow-up phase: Patients undergo core tissue biopsies at baseline and at 3 months for genomic and gene expression analysis. Insulin-like growth factor 1 (IGF-1) and selenium-binding protein 1 levels are measured by quantitative reverse transcription-polymerase chain reaction (PCR). Patients also undergo blood sample collection periodically for biomarker analysis, proteomic analysis, and for telomere length and telomerase activity analysis as measured by quantitative PCR and telomerase repeat amplification protocol (TRAP). Blood and urine samples are also collected and stored for future analysis.
Patients complete questionnaires at baseline, at 3 months, and then every 6-12 months for up to 3 years to assess dietary and lifestyle behaviors (exercise, stress management practice, and group support), quality of life, and psychological adjustment. Questionnaires include the Semi-Quantitative Food Frequency Questionnaire; the SF-36 Health Survey; the UCLA Prostate Cancer Index; the Impact of Event Scale; the Memorial Anxiety Scale for Prostate Cancer; the Post Traumatic Growth Inventory; the Mindful Attention Awareness Scale; and the Received Social Support subscale from the Berlin Social Support Scale.
Patients' medical records are reviewed every 6-12 months for up to 3 years to collect information on clinical events and biomarkers (e.g., prostate-specific antigen and Gleason score).
研究の種類
入学 (予想される)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate
- Has undergone an extended pattern biopsy (defined as 8+ cores) within the past 2 years OR is scheduled to undergo an extended pattern clinical biopsy within 6 weeks of starting study intervention and is willing to undergo 4 additional research core biopsies
- No more than 33% of biopsy cores positive (> 33% of biopsy cores positive allowed if due to microfoci of adenocarcinoma)
- No more than 50% of the length of a tumor core involved by carcinoma
- Clinical stage T1 or T2a disease
- Previously untreated disease
- Gleason score ≤ 6 with no pattern 4 or 5 histology (Gleason pattern 4 seen as a microfocus [< 2 mm in length] allowed)
Prostate-specific antigen (PSA) ≤ 10.0 ng/mL (PSA < 15 ng/mL allowed for patients with benign prostatic hyperplasia or prostatitis)
Must have had 3 serum PSA levels performed ≥ 2 weeks apart over the past year to allow calculation of a PSA doubling time
- No PSA doubling time of < 3 months
- Has chosen watchful waiting as treatment
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Living in the greater San Francisco Bay Area
- Willing to make comprehensive lifestyle changes
- Baseline dietary fat intake ≥ 15%
- Able to participate in the exercise portion of this study, as determined by the cardiologist or primary care physician
- No limited exercise tolerance precluding participation in the lifestyle intervention component of this study
- No comprehensive lifestyle change similar to the lifestyle intervention used in this study
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Coronary artery disease requiring a revascularization procedure
- Cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
No prior or other concurrent treatment for prostate cancer, including any of the following:
- Surgery
- Radiotherapy
- Hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol acetate, nilutamide, or DES/estrogen)
- Chemotherapy
- PC-SPES
- Investigational agents
- More than 4 weeks since prior and no concurrent finasteride or dutasteride
- More than 4 weeks since prior and no concurrent saw palmetto or any other herbal/nutritional preparation that would affect hormone levels
- More than 4 weeks since prior multivitamin/mineral and/or supplemental soy protein, vitamin E, vitamin C, selenium, fish oil, or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids
- More than 1 month since prior and no concurrent NSAIDs, COX-2-inhibitors, and/or aspirin used for > 7 consecutive days
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
---|
Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention
|
二次結果の測定
結果測定 |
---|
Correlation of quality of life changes and adherence to dietary and lifestyle changes with gene expression outcomes
|
Telomere length and telomerase activity in blood samples in response to the dietary and lifestyle intervention as measured by quantitative polymerase chain reaction and telomerase repeat amplification protocol (TRAP)
|
協力者と研究者
捜査官
- 主任研究者:Peter R. Carroll, MD、University of California, San Francisco
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CDR0000612335
- UCSF-H5664-25348
- UCSF CC#04553
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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