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Venlafaxine for Hot Flashes After Breast Cancer

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ClinicalTrials.gov Identifier: NCT00198250
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 14, 2008
Vanderbilt University
Information provided by:
Indiana University

Brief Summary:
The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity of venlafaxine hydrochloride and identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: venlafaxine Phase 2

Detailed Description:
Hot flashes are the most severe and fourth most prevalent menopausal symptom reported by women with breast cancer. Hot flashes affect over 65% of this population, with 59% rating the symptom as severe and 44% reporting they are extremely distressed by the symptom. Despite the high prevalence, severity and distress associated with this symptom, the scientific basis for managing hot flashes in women with breast cancer is limited. This randomized, double-blind, placebo-controlled crossover trial examines the effectiveness and toxicity of sustained release venlafaxine hydrochloride (37.5 mg po qd) on hot flashes in women following treatment for breast cancer. Venlafaxine is a phenylethylamine derivative that potently inhibits the reuptake of neuronal serotonin and norepinephrine and weakly inhibits the reuptake of dopamine. A secondary aim of this project is to examine the impact of hot flashes on psychological, behavioral, and physical outcomes. This study is based on the Wickham Symptom Management Model which depicts interrelationships between symptoms, symptom management strategies, and symptom management outcomes. Participants (n = 80) who are at least one month post-completion of surgery, radiation, and/or chemotherapy and who have been on tamoxifen (if prescribed) for at least six weeks will complete a two-week baseline hot flash assessment and be randomized to one arm of the crossover trial. At the end of the first six-week arm, participants will crossover to the opposite study arm for an additional six weeks. Outcomes to be assessed include effectiveness of the intervention (hot flash frequency, severity, distress and magnitude), toxicity of the intervention (subjective preference, side effects), psychological outcomes (mood disturbance), behavioral outcomes (quality of life, interference with daily activities) and physical outcomes (fatigue and sleep disturbance). Hot flashes will be measured daily, using a subjective, prospective diary methodology, and weekly, using objective state-of-the art 24-hour physiological monitoring of sternal skin conductance. Other outcomes will be measured weekly. Compliance with the intervention/placebo will be assessed weekly using medication blister pack cards. Timing of outcome assessments is based on limitations of the physiological monitoring device and expected timing of treatment effects. Summary statistics (i.e., mean, slope, maximum response, range, proportion, achievable difference) will be used to effectively reduce the design to a 2 X 2 crossover and data will be analyzed accordingly (i.e., t-tests, linear regression, GEE, mixed model). Study findings will significantly contribute to the scientific basis of hot flash management in women following treatment for breast cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Venlafaxine for Hot Flashes After Breast Cancer
Study Start Date : May 2000
Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Drug: venlafaxine
    Venlafaxine taper dose from 37.5mg for one week to 75 mg for 3 weeks
    Other Name: Effexor

Primary Outcome Measures :
  1. Assess the effectiveness venlafaxine hydrochloride versus placebo in alleviating hot flash frequency, severity, distress, and magnitude in women following treatment for breast cancer. [ Time Frame: completed ]

Secondary Outcome Measures :
  1. Identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer. [ Time Frame: completed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women at least 21 years of age
  • willing and able to provide informed consent
  • first time diagnosis of breast cancer
  • no other history of cancer
  • considered disease free at time of study enrollment
  • at least four weeks post-completion of surgery, radiation, and/or chemotherapy for non-metastatic cancer
  • experiencing daily hot flashes
  • desirous of treatment for hot flashes, but not concurrently using any other hot flash treatments
  • living within 60 miles of Indianapolis
  • able to read, write and speak English

Exclusion Criteria:

  • current treatment with antidepressants for depression, neuropathic pain or hot flashes
  • diagnosis of metastatic breast cancer (stage IV)
  • treatment for hot flashes within the past four weeks, including (a) soy supplements; (b) botanicals, such as dong quai (Angelica sinensis), black cohosh, ginseng, gotu kola, licorice root, chaste tree, sage, or wild yam root; (c) vitamin E; or (d) prescription medications, such as clonidine hydrochloride or megestrol acetate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198250

United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Vanderbilt University
Principal Investigator: Janet S Carpenter, PhD Indiana University School of Medicine

Responsible Party: Janet S. Carpenter, Indiana University
ClinicalTrials.gov Identifier: NCT00198250     History of Changes
Other Study ID Numbers: 0308-07
NINR/NIH R01 NR05261
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Indiana University:
Breast cancer survivorship
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs