Official Title: “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”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: gabapentin

Primary Measures

• Hot flash reduction by diary record at 4 weeks

Secondary Measures

• Toxicity by questionnaires at 4 weeks

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
• Menopausal status
• Not specified
• Performance status
• ECOG 0-1
• Life expectancy
• At least 6 months
• Hematopoietic
• Not specified
• Hepatic
• Not specified
• Renal
• Not specified
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• 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
• Radiotherapy
• Not specified
• Surgery
• Not specified
• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Central Cancer Treatment Group

Overall Clinical Trial Officials and Contacts

Charles L. Loprinzi, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00087399

Study ID Number: CDR0000374993

ClinicalTrials.gov Identifier: NCT00087399

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database