Venlafaxine and gabapentin for the management of hot flashes in breast cancer survivors: a randomized crossover trial

Completed

Conditions: Breast cancer
Cancer

Registration Number: ISRCTN12237417

Lead Sponsor: Canadian Breast Cancer Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 120

Inclusion Criteria

1. Women with a history of breast cancer, ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease and who have completed chemotherapy or radiation therapy for 8 weeks)
2. Age 18 or above
3. Bothersome hot flashes (at least 14 hot flashes per week and of sufficient severity for the patients to desire pharmacologic intervention)
4. Presence of hot flashes for at least one month prior to study entry
5. Life expectancy of at least six months
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Normal creatinine clearance

Exclusion Criteria

1. Previous use of venlafaxine or the use of any other antidepressants (including St. John's Wort) within a year prior to study entry
2. Current (less than or equal to 2 weeks) or planned use of other agents for the treatment of hot flashes
3. Calcium channel antagonist or gabapentin within two weeks of study entry
4. Tamoxifen, aromatase inhibitors and gonadotropin-releasing hormone (GnRH) analogues are allowed unless started less than or equal to 4 weeks and or if the plan is to stop these agents during the study period (i.e. 12 weeks)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare patient preference for venlafaxine versus gabapentin in a randomized crossover single blind trial

Secondary Outcome Measures

Name	Time	Method
1. To compare hot flash frequency, severity, and composite scores<br>2. To compare quality of life measured using the medical outcomes study-short form 36 (MOS-SF36) and mood measured using the profile of mood states (POMS)<br>3. To compare toxicities<br>4. To correlate patient preferences with standard outcome measurements