Venlafaxine for Hot Flashes After Breast Cancer

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: November 2005
• Actual Study Completion Date: November 2005

Arms and Interventions

Intervention Details:

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes 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

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 of Results:

Carpenter JS, Storniolo AM, Johns S, Monahan PO, Azzouz F, Elam JL, Johnson CS, Shelton RC. Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist. 2007 Jan;12(1):124-35.

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

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; 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