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ISRCTN
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ISRCTN12237417
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ClinicalTrials.gov identifier
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Public title
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Venlafaxine and gabapentin for the management of hot flashes in breast cancer survivors: a randomized crossover trial
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Scientific title
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Acronym
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Vibrant Study
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Serial number at source
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N/A
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Study hypothesis
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We hypothesize that breast cancer survivors will prefer gabapentin over venlafaxine based on perceived lower side effects and equivalent efficacy.
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Lay summary
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Ethics approval
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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)
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Study design
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Randomized crossover open-label trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/07/2006
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Anticipated end date
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01/07/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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Venlafaxine versus gabapentin
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Primary outcome measure(s)
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To compare patient preference for venlafaxine versus gabapentin in a randomized crossover single blind trial
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Breast Cancer Foundation (Canada)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21060031
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Contact name
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Dr
Louise
Bordeleau
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Address
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600 University Avenue
Room 1286
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City/town
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Toronto
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Zip/Postcode
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M5G 1X5
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Country
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Canada
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Sponsor
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Canadian Breast Cancer Foundation
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Address
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600 University Avenue
Room 1286
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City/town
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Toronto
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Zip/Postcode
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M5C 2N8
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Country
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Canada
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Sponsor website:
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http://www.cbcf.org/ontario
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Date applied
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10/05/2006
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Last edited
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27/01/2011
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Date ISRCTN assigned
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05/06/2006
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