Condition category
Cancer
Date applied
10/05/2006
Date assigned
05/06/2006
Last edited
27/01/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Louise Bordeleau

ORCID ID

Contact details

600 University Avenue
Room 1286
Toronto
M5G 1X5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

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)

Study design

Randomized crossover open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Venlafaxine versus gabapentin

Intervention type

Drug

Phase

Not Specified

Drug names

Gabapentin, venlafaxine

Primary outcome measures

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 trial start date

01/07/2006

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

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

Locations

Countries of recruitment

Canada

Trial participating centre

600 University Avenue
Toronto
M5G 1X5
Canada

Sponsor information

Organisation

Canadian Breast Cancer Foundation

Sponsor details

600 University Avenue
Room 1286
Toronto
M5C 2N8
Canada

Sponsor type

Charity

Website

http://www.cbcf.org/ontario

Funders

Funder type

Charity

Funder name

Canadian Breast Cancer Foundation (Canada)

Alternative name(s)

Fondation Canadienne du Cancer du Sein, CBCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21060031

Publication citations

  1. Results

    Bordeleau L, Pritchard KI, Loprinzi CL, Ennis M, Jugovic O, Warr D, Haq R, Goodwin PJ, Multicenter, randomized, cross-over clinical trial of venlafaxine versus gabapentin for the management of hot flashes in breast cancer survivors., J. Clin. Oncol., 2010, 28, 35, 5147-5152, doi: 10.1200/JCO.2010.29.9230.

Additional files

Editorial Notes