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



Status:Completed
Conditions:Breast Cancer, Cancer, Hot Flash
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2004
End Date:April 2007

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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

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.

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.

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
We found this trial at
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