Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hot Flashes |
Drug: gabapentin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| 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 |
- Hot flash reduction by diary record at 4 weeks
- Toxicity by questionnaires at 4 weeks
| Study Start Date: | November 2004 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 162 Study Locations| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
| Investigator: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00087399 History of Changes |
| Other Study ID Numbers: | CDR0000374993, NCCTG-N03C5 |
| Study First Received: | July 8, 2004 |
| Last Updated: | November 21, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
breast cancer hot flashes |
Additional relevant MeSH terms:
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Antidepressive Agents Gabapentin Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 19, 2013