Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N03C5 NCT00087399

Objectives

1. 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.
2. Compare adverse events in patients treated with these regimens.
3. Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.

Outcomes

Hot flash reduction by diary record at 4 weeks

Toxicity by questionnaires at 4 weeks

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.

Loprinzi CL, Kugler JW, Barton DL, et al.: Phase III 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: NCCTG N03C5. J Clin Oncol 25 (3): 308-12, 2007.[PUBMED Abstract]

Loprinzi CL, Kugler JW, Barton DL, et al.: Phase III randomized trial to evaluate the use of gabapentin alone vs with continuing an antidepressant in women failing an antidepressant for the treatment of hot flashes: North Central Cancer Treatment Group study N03C5. [Abstract] J Clin Oncol 24 (Suppl 18): A-526, 9s, 2006.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu
Debra Barton, RN, PhD, AOCN, Protocol co-chair		Ph: 507-284-2511

Registry Information
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
Trial Start Date		2004-11-19
Registered in ClinicalTrials.gov		NCT00087399
Date Submitted to PDQ		2004-06-07
Information Last Verified		2005-08-16
NCI Grant/Contract Number		CA25224