NCT00082732

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Jul 2000

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2000

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2006

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

5.6 years

First QC Date

May 14, 2004

Last Update Submit

November 5, 2018

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage II prostate canceradenocarcinoma of the prostate

Study Arms (2)

Arm I: Dietary Intervention

EXPERIMENTAL

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.

Behavioral: behavioral dietary interventionDietary Supplement: dietary interventionProcedure: therapeutic dietary intervention

Arm II: Observation

NO INTERVENTION

Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.

Interventions

behavioral dietary interventionBEHAVIORAL
Arm I: Dietary Intervention
dietary interventionDIETARY_SUPPLEMENT
Arm I: Dietary Intervention
therapeutic dietary interventionPROCEDURE
Arm I: Dietary Intervention

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Richard J. Babaian, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

July 28, 2000

Primary Completion

February 27, 2006

Study Completion

February 27, 2006

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

US(1)