Clinical trial · Interventional
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
NCT00354432CI-TRIAL-00054127terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped by the DSMB for lack of effect per interim stopping rule.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral soy protein/isoflavones powder | Dietary Supplement | — | UNRESOLVED |
| Placebo Pill | Drug | — | UNRESOLVED |
| Placebo Powder | Dietary Supplement | — | UNRESOLVED |
| Venlafaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm I - Placebo
- description
- Patients receive oral placebo pill and oral placebo powder once daily.
- interventionNames
- Dietary Supplement: Placebo Powder
- Drug: Placebo Pill
- type
- ACTIVE_COMPARATOR
- label
- Arm II - Soy
- description
- Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
- interventionNames
- Dietary Supplement: oral soy protein/isoflavones powder
- Drug: Placebo Pill
- type
- EXPERIMENTAL
- label
- Arm III - Venlafaxine
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of prostate cancer, any stage Life expectancy of \> nine months * Prior or current androgen deprivation for treatment or control of prostate cancer to include: * Bilateral Orchiectomy * LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents * Chemotherapy * Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate + seminal vesicles, and/or pelvis). Seed implants are allowed * Participant report of hot flash frequency of an average of four or more per day, as defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per week) * Hot flashes must be moderate or severe (See appendix A for hot flash definitions) * Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3 minutes * Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last longer and interfere with ongoing activity * Age \>21 * No allergies to soy or dairy products * No current use of SSRIs, SNRI's, MAOIs, or Linezolide * No uncontrolled hypertension (160/90) or greater than Class I American Heart Association functional capacity * No history of mania, hypomania, bipolar disorder, or anorexia nervosa * No history of seizures * No history of hepatic dysfunction) * Must have a telephone * Signed protocol-specific Informed Consent * Participants consuming soy foods or soy based supplements must continue on a stable regimen during study participation * Patients should maintain same treatment and medications for prostate cancer throughout entire study. * No change in treatment for 2 weeks prior to registration. * Current use of medications and herbal supplements for hot flashes are allowed if on a stable regimen throughout the entire study. (Does not include anti-depressants) Exclusion Criteria: * Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation, changes in chemotherapy) * Concurrent antidepressant therapy * History of intolerance to venlafaxine * Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective norepinephrine reuptake inhibitor) * History of seizure disorder
References
Publications (1)
- DERIVEDVitolins MZ, Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, Frizzell B, Lesser GJ, Naughton M, Radford JE Jr, Shaw EG. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. J Clin Oncol. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30. PMID 24081940