Soy Protein/Effexor Hormone Therapy for Prostate Cancer

NCT ID: NCT00354432

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-01
• Study Completion Date: 2010-08-01

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer.

Secondary

• Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients.
• Monitor and assess the participant drop out rate.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to severity of disease (metastatic vs nonmetastatic) and baseline severity of hot flashes. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
• Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.
• Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.
• Arm IV: Patients receive oral placebo pill and oral placebo powder once daily. Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks of treatment, patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week.

Patients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment. Quality of life is assessed at baseline and at week 12.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Conditions

Hot Flashes; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm I - Placebo

Patients receive oral placebo pill and oral placebo powder once daily.

Group Type: ACTIVE_COMPARATOR

Placebo Powder

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo Pill

Intervention Type: DRUG

Patients receive oral placebo pill.

Arm II - Soy

Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.

Group Type: ACTIVE_COMPARATOR

oral soy protein/isoflavones powder

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo Pill

Intervention Type: DRUG

Patients receive oral placebo pill.

Arm III - Venlafaxine

Patients receive oral Venlafaxine pill and placebo powder once daily.

Group Type: EXPERIMENTAL

Venlafaxine

Intervention Type: DRUG

Patients receive oral venlafaxine 75mg.

Placebo Powder

Intervention Type: DIETARY_SUPPLEMENT

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

Arm IV - Soy + Venlafaxine

Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.

Group Type: PLACEBO_COMPARATOR

oral soy protein/isoflavones powder

Intervention Type: DIETARY_SUPPLEMENT

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

Venlafaxine

Intervention Type: DRUG

Patients receive oral venlafaxine 75mg.

Interventions

oral soy protein/isoflavones powder

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

Intervention Type: DIETARY_SUPPLEMENT

Venlafaxine

Patients receive oral venlafaxine 75mg.

Intervention Type: DRUG

Placebo Powder

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo Pill

Patients receive oral placebo pill.

Intervention Type: DRUG

Other Intervention Names

Protein powder; Supplement powder soy and casein 20gm; Isoflavones; Isocaloric supplement; Casein protein; Effexor XR; placebo; Casein; Sugar Pill

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mara Vitolins, DrPH, RD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

CCOP - Christiana Care Health Services

Newark, Delaware, United States

MBCCOP - JHS Hospital of Cook County

Chicago, Illinois, United States

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

CCOP - Beaumont

Royal Oak, Michigan, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

CCOP - Heartland Research Consortium

St Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, United States

Southeastern Medical Oncology Center - Goldsboro

Goldsboro, North Carolina, United States

Caldwell Memorial Hospital

Lenoir, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Wake Forest University CCOP Research Base

Winston-Salem, North Carolina, United States

Cancer Centers of the Carolinas - Easley

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Countries

United States

References

Vitolins 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.

Reference Type: DERIVED

PMID: 24081940 (View on PubMed)

Other Identifiers

U10CA081851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REBAcccwfu97405

Identifier Type: -

Identifier Source: org_study_id