Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

Study Overview
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Brief Summary
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RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes. PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Hot Flashes

Intervention / Treatment
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* Drug: gabapentin
* Drug: antidepressant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gabapentin + antidepressant<br>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. Patients complete a hot flash diary at baseline and then daily during study treatment. | Drug: gabapentin<br> <br> Drug: antidepressant<br> <br> |
| Experimental: gabapentin<br>Patients receive 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. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment. | Drug: gabapentin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash reduction by diary record at 4 weeks |  | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity by questionnaires at 4 weeks |  | at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hot flashes