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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00087399

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 III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Antidepressants Breast Cancer Cancer

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Hot flash reduction by diary record at 4 weeks

Secondary Outcome Measures:

Toxicity by questionnaires at 4 weeks

Study Start Date:	November 2004
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087399

Show 162 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Charles L. Loprinzi, MD	Mayo Clinic
Investigator:	Debra Barton, RN, PhD, AOCN, FAAN	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso SW, Johnson DB, Jaslowski AJ. 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. 2007 Jan 20;25(3):308-12. Epub 2006 Dec 4.

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.

Study ID Numbers:	CDR0000374993, NCCTG-N03C5
Study First Received:	July 8, 2004
Last Updated:	November 21, 2009
ClinicalTrials.gov Identifier:	NCT00087399 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer
hot flashes

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hot Flashes
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Membrane Transport Modulators
Signs and Symptoms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses

Analgesics
Antidepressive Agents
Breast Diseases
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Skin Diseases
Central Nervous System Depressants
Breast Neoplasms
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Neoplasms
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010