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Soy Protein/Effexor Hormone Therapy for Prostate Cancer

NCT00354432 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-28

Study results available
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Summary

RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.

PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.

Conditions

Interventions

DIETARY_SUPPLEMENT

oral soy protein/isoflavones powder

Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein

DRUG

Venlafaxine

Patients receive oral venlafaxine 75mg.

DIETARY_SUPPLEMENT

Placebo Powder

Placebo powder (20gm casein protein) orally 0 mg of total isoflavones

DRUG

Placebo Pill

Patients receive oral placebo pill.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mara Vitolins, DrPH, RD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-01
Primary Completion
2010-08-01
Completion
2010-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00354432 on ClinicalTrials.gov