Hot FlashesPhase 3NCT00354432
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
A Phase 3 study testing oral soy protein/isoflavones powder and Venlafaxine in people with Hot Flashes and Prostate Cancer, run by Wake Forest University Health Sciences at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Hot Flashes, Prostate Cancer
- What is being tested?
- oral soy protein/isoflavones powder and Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Feb 2007to 1 Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612
CCOP - Central Illinois
Decatur, Illinois, 62526
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
Cancer Centers of the Carolinas - Easley
Greenville, South Carolina, 29615
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804
CCOP - Heartland Research Consortium
St Louis, Missouri, 63131
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Wake Forest University CCOP Research Base
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
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.
Read the 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
- Being tested
- oral soy protein/isoflavones powder, Venlafaxine, Placebo Powder, Placebo Pill
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral soy protein/isoflavones powderDietary supplement
Also called Protein powder, Supplement powder soy and casein 20gm, Isoflavones, Isocaloric supplement
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
VenlafaxineDrug
Also called Effexor XR, placebo
Patients receive oral venlafaxine 75mg.
Placebo PowderDietary supplement
Also called Casein
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Placebo PillDrug
Also called Sugar Pill
Patients receive oral placebo pill.
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Placebo | Active comparator | Patients receive oral placebo pill and oral placebo powder once daily. Receives: Dietary Supplement: Placebo Powder; Drug: Placebo Pill |
| Arm II - Soy | Active comparator | Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily. Receives: Dietary Supplement: oral soy protein/isoflavones powder; Drug: Placebo Pill |
| Arm III - Venlafaxine | Experimental | Patients receive oral Venlafaxine pill and placebo powder once daily. Receives: Drug: Venlafaxine; Dietary Supplement: Placebo Powder |
| Arm IV - Soy + Venlafaxine | Placebo comparator | Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily. Receives: Dietary Supplement: oral soy protein/isoflavones powder; Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash Symptom Severity Score
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 better outcome.
Measured: 12 weeks
Secondary outcomes (1)
Quality of Life
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study start1 Feb 2007
- Primary completion1 Aug 2010
- Study completion1 Aug 2010
Why it stopped: Stopped by the DSMB for lack of effect per interim stopping rule.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mara Vitolins, DrPH, RD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354432
- Sponsor's protocol ID
- REBAcccwfu97405
- Other IDs
- U10CA081851
- Status last verified
- Sep 2021
- First submitted
- 19 Jul 2006
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24081940
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00354432
- Acronym / sponsor ID
- REBAcccwfu97405
- Conditions
- Hot Flashes, Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped by the DSMB for lack of effect per interim stopping rule.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2007 (actual)
- Primary completion
- 1 Aug 2010 (actual)
- Study completion
- 1 Aug 2010 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I - Placebo | Active comparator | Dietary Supplement: Placebo Powder, Drug: Placebo PillPatients receive oral placebo pill and oral placebo powder once daily. |
| Arm II - Soy | Active comparator | Dietary Supplement: oral soy protein/isoflavones powder, Drug: Placebo PillPatients receive oral placebo pill and oral soy protein/isoflavones powder once daily. |
| Arm III - Venlafaxine | Experimental | Drug: Venlafaxine, Dietary Supplement: Placebo PowderPatients receive oral Venlafaxine pill and placebo powder once daily. |
| Arm IV - Soy + Venlafaxine | Placebo comparator | Dietary Supplement: oral soy protein/isoflavones powder, Drug: VenlafaxinePatients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral soy protein/isoflavones powderAlso: Protein powder, Supplement powder soy and casein 20gm, Isoflavones, Isocaloric supplementSoy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein | Dietary supplement | Arm II - Soy, Arm IV - Soy + Venlafaxine |
| VenlafaxineAlso: Effexor XR, placeboPatients receive oral venlafaxine 75mg. | Drug | Arm III - Venlafaxine, Arm IV - Soy + Venlafaxine |
| Placebo PowderAlso: CaseinPlacebo powder (20gm casein protein) orally 0 mg of total isoflavones | Dietary supplement | Arm I - Placebo, Arm III - Venlafaxine |
| Placebo PillAlso: Sugar PillPatients receive oral placebo pill. | Drug | Arm I - Placebo, Arm II - Soy |
Primary outcome
Hot Flash Symptom Severity Score
Time frame: 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 better outcome.
1 secondary outcome
Quality of Life
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24081940Vitolins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Vitolins, DrPH, RD study chair
Wake Forest University Health Sciences
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral soy protein/isoflavones powder and Venlafaxine in people with Hot Flashes and Prostate Cancer, run by Wake Forest University Health Sciences at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash Symptom Severity Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.