Venlafaxine for Hot Flashes After Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00198250
First received: September 15, 2005
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Breast Cancer
Drug: venlafaxine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Venlafaxine for Hot Flashes After Breast Cancer

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer. [ Time Frame: completed ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: May 2000
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: venlafaxine
    Venlafaxine taper dose from 37.5mg for one week to 75 mg for 3 weeks
    Other Name: Effexor
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198250

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

Publications:
Responsible Party: Janet S. Carpenter, Indiana University
ClinicalTrials.gov Identifier: NCT00198250     History of Changes
Other Study ID Numbers: 0308-07, NINR/NIH R01 NR05261
Study First Received: September 15, 2005
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Breast cancer survivorship
hot flashes
treatment

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014