A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
gabapentin
+ antidepressant
Breast Diseases+6
+ Breast Neoplasms
+ Neoplasms
Supportive Care Study
Summary
Study start date: November 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: * Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer. * Compare adverse events in patients treated with these regimens. * Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. * Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule). Patients in both arms complete a hot flash diary at baseline and then daily during study treatment. Quality of life is assessed at baseline and then weekly during study treatment. PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.118 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer * Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant * Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant * No monoamine oxidase inhibitors or tricyclics * No current evidence of malignant disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Performance status * ECOG 0-1 Life expectancy * At least 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Chemotherapy * More than 4 weeks since prior antineoplastic chemotherapy * No concurrent antineoplastic chemotherapy Endocrine therapy * More than 4 weeks since prior androgens, estrogens, or progestational agents * More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes * No concurrent androgens, estrogens, or progestational agents, including oral contraceptives * No concurrent DHEA for treatment of hot flashes * Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment Other * No prior gabapentin * More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®) * Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment * No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®) * No other concurrent antidepressants
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 162 locations
Trinity Medical Center - East
Moline, United StatesBroMenn Regional Medical Center
Normal, United StatesFremont Area Medical Center
Fremont, United States