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

ISRCTN	ISRCTN12237417
DOI	https://doi.org/10.1186/ISRCTN12237417
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Louise Bordeleau
Scientific

600 University Avenue
Room 1286
Toronto
M5G 1X5
Canada

Study design	Randomized crossover open-label trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Vibrant Study
Study hypothesis	We hypothesize that breast cancer survivors will prefer gabapentin over venlafaxine based on perceived lower side effects and equivalent efficacy.
Ethics approval(s)	Mount Sinai Hospital Research Ethics Board intial approval on 6th July 2006 (last continued approval is 8th July 2008) (ref: MSH REB # 06-0145-A)
Condition	Breast cancer
Intervention	Venlafaxine versus gabapentin
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gabapentin, venlafaxine
Primary outcome measure	To compare patient preference for venlafaxine versus gabapentin in a randomized crossover single blind trial
Secondary outcome measures	1. To compare hot flash frequency, severity, and composite scores 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) 3. To compare toxicities 4. To correlate patient preferences with standard outcome measurements
Overall study start date	01/07/2006
Overall study end date	01/07/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	120
Participant 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
Participant 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)
Recruitment start date	01/07/2006
Recruitment end date	01/07/2009

600 University Avenue

Toronto
M5G 1X5
Canada

Canadian Breast Cancer Foundation
Charity

600 University Avenue
Room 1286
Toronto
M5C 2N8
Canada

Website	http://www.cbcf.org/ontario

Charity

Canadian Breast Cancer Foundation (Canada)
Government organisation / Associations and societies (private and public)

Alternative name(s): Société canadienne du cancer, cancersociety, Canadian Cancer Society (Canada), CCS, SCC
Location: Canada

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/12/2010		Yes	No