Clinical trial · Interventional
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractory prostate cancer. Nutrition counseling may help motivate patients to follow this diet. PURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary interventions, such as receiving nutrition counseling, in helping patients who have hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| dietary intervention | Dietary Supplement | — | UNRESOLVED |
| therapeutic dietary intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Dietary Intervention
- description
- Nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52.
- interventionNames
- Behavioral: behavioral dietary intervention
- Dietary Supplement: dietary intervention
- Procedure: therapeutic dietary intervention
- type
- NO_INTERVENTION
- label
- Arm II: Observation
- description
- Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * No small cell component * No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, computed tomography (CT) scan, or transrectal ultrasound * No clinical symptoms within the past 90 days * Documented biochemical failure after radical prostatectomy * Prostate-specific antigen must have initially nadired to an undetectable level (\< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL) * Serum testosterone \> 100 ng/dL PATIENT CHARACTERISTICS: Age * Any age Performance status * Zubrod 0-1 Life expectancy * At least 1 year Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No known allergic reactions to milk or soy products PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 1 year since prior chemotherapy Endocrine therapy * More than 1 year since prior hormonal therapy Radiotherapy * Not specified Surgery * See Disease Characteristics
References
Publications (0)
Data not yet available