NCT00354432

Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Terminated Phase 3 Results posted Last updated 28 September 2021

What this trial tests

Phase 3 trial testing oral soy protein/isoflavones powder in Hot Flashes in 120 participants. Terminated before completion.

Timeline

1 February 2007

Primary endpoint
1 August 2010

1 August 2010

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	supportive care
Enrollment	120
Start date	1 February 2007
Primary completion	1 August 2010
Estimated completion	1 August 2010
Sites	20 locations across United States

Drugs / interventions tested

• oral soy protein/isoflavones powder
• Venlafaxine — full drug profile →
• Placebo Powder
• Placebo Pill — full drug profile →

Conditions studied

• Hot Flashes — all drugs for Hot Flashes →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

21 and older, male only, with Hot Flashes or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hot Flash Symptom Severity Score Primary · 12 weeks

The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a bett

Group	Value	95% CI
Arm I - Placebo	52.3	± 10.8
Arm II - Soy	77.2	± 11.6
Arm III - Venlafaxine	68.9	± 12.1
Arm IV - Soy + Venlafaxine	73.8	± 11.9

Quality of Life Secondary · 12 weeks

Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.

Group	Value	95% CI
Arm I - Placebo	115.6	± 2.4
Arm II - Soy	121.5	± 2.5
Arm III - Venlafaxine	114.3	± 2.7
Arm IV - Soy + Venlafaxine	117.7	± 2.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I - Placebo

Serious: 4/30 (13%)

Deaths: —

Arm II - Soy

Serious: 5/27 (19%)

Deaths: —

Arm III - Venlafaxine

Serious: 5/29 (17%)

Deaths: —

Arm IV - Soy + Venlafaxine

Serious: 5/28 (18%)

Deaths: —

Serious adverse events (12 terms)

Reaction	System	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxine
Erectile Dysfunction	Reproductive system and breast disorders	—	—	—	—
Pain - Other	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Infection - Rectum	Infections and infestations	—	—	—	—
Insomnia	General disorders	—	—	—	—
Mood alteration - Agitation	General disorders	—	—	—	—
Mood alteration- Anxiety	Nervous system disorders	—	—	—	—
Obstruction - Ureter	Renal and urinary disorders	—	—	—	—
Pain - chest NOS	General disorders	—	—	—	—
Pain - joint	Musculoskeletal and connective tissue disorders	—	—	—	—
Somnolence	General disorders	—	—	—	—
Vascular - other	Vascular disorders	—	—	—	—

Other adverse events (30 terms — click to expand)

Reaction	System	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxine
Sweating - Diaphoresis	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Ejaculatory Dysfunction	Reproductive system and breast disorders	—	—	—	—
Erectile Dysfunction	Reproductive system and breast disorders	—	—	—	—
Insomnia	General disorders	—	—	—	—
Pain - Other	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Distension/Bloating, Abdominal	Gastrointestinal disorders	—	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Mood Alteration - Agitation	Psychiatric disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Dizziness	Ear and labyrinth disorders	—	—	—	—
Diarrhea - without colostomy	Gastrointestinal disorders	—	—	—	—
Mood Alteration - Anxiety	Psychiatric disorders	—	—	—	—
Anorexia	General disorders	—	—	—	—
Somnolence	Psychiatric disorders	—	—	—	—
Confusion	Nervous system disorders	—	—	—	—
Constitutional Symptioms - Nightmares	General disorders	—	—	—	—
Neurology - Nervousness	Nervous system disorders	—	—	—	—
Urinary Frequency/Urgency	Renal and urinary disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Allergic Reaction/hypersensitivity including drug reaction	General disorders	—	—	—	—
Neuropathy - Sensory	Nervous system disorders	—	—	—	—
Pain - Back	General disorders	—	—	—	—
Pain - Extremity - Limb	General disorders	—	—	—	—
Pain - joint	Musculoskeletal and connective tissue disorders	—	—	—	—
Petechiae/purpura - hemorrhage/bleeding into skin or mucosa	Skin and subcutaneous tissue disorders	—	—	—	—
Renal/Genitourinary - Other (Specify, __)	Renal and urinary disorders	—	—	—	—

Most-reported serious reactions: Erectile Dysfunction, Pain - Other, Fatigue, Infection - Rectum, Insomnia, Mood alteration - Agitation, Mood alteration- Anxiety, Obstruction - Ureter.

Data from ClinicalTrials.gov NCT00354432 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Harnessing the fruits of nature for the development of multi-targeted cancer therapeutics.
   Sarkar FH, Li Y. · · 2009 · cited 88× · PMID 19660870 · DOI 10.1016/j.ctrv.2009.07.001
2. Role of phytoestrogens in cancer therapy.
   Virk-Baker MK, Nagy TR, Barnes S. · · 2010 · cited 44× · PMID 20597043 · DOI 10.1055/s-0030-1250074
3. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.
   Vitolins MZ, Griffin L, Tomlinson WV, Vuky J, et al · · 2013 · cited 32× · PMID 24081940 · DOI 10.1200/jco.2012.48.1432