Status:
COMPLETED
Venlafaxine for Hot Flashes After Breast Cancer
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Vanderbilt University
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
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 venlafaxi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00198250
Start Date
May 1 2000
End Date
November 1 2005
Last Update
November 14 2008
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202