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

Condition(s) targeted: Breast Cancer; Hot Flashes

Intervention: gabapentin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: North Central Cancer Treatment Group

Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Study Chair, Affiliation: Mayo Clinic
Debra Barton, RN, PhD, Affiliation: Mayo Clinic

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.

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

Study design: Supportive Care, Randomized, Active Control

Primary outcome: Hot flash reduction by diary record at 4 weeks

Secondary outcome: Toxicity by questionnaires at 4 weeks

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224-9980, United States

MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia 30912, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Eureka Hospital, Eureka, Illinois 61530, United States

Galesburg Clinic, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Graham Hospital, Canton, Illinois 61520, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois 61401, United States

Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Kewanee Hospital, Kewanee, Illinois 61443, United States

Mason District Hospital, Havana, Illinois 62644, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois 61350, United States

Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois 61615, United States

OSF St. Francis Medical Center, Peoria, Illinois 61637, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

St. Joseph Medical Center, Bloomington, Illinois 61701, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

Trinity Medical Center - East, Moline, Illinois 61265, United States

Valley Cancer Center, Spring Valley, Illinois 61362, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

St. Francis Hospital and Health Centers, Beech Grove, Indiana 46107, United States

Alegent Health Community Memorial Hospital, Missouri Valley, Iowa 51555, United States

Alegent Health Mercy Hospital, Council Bluffs, Iowa 51503, United States

Burgess Health Center, Onawa, Iowa 51040, United States

Cancer Center at Ottumwa Regional Health Center, Ottumwa, Iowa 52501, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

McFarland Clinic, P.C., Ames, Iowa 50010, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa 50266, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa 50401, United States

Mercy Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa 52403, United States

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Saint Anthony Regional Hospital, Carroll, Iowa 51401, United States

Siouxland Hematology-Oncology Associates, Sioux City, Iowa 51101, United States

Siouxland Regional Cancer Center, Sioux City, Iowa 51101-1733, United States

St. Luke's Hospital, Cedar Rapids, Iowa 52402, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Associates in Womens Health, Wichita, Kansas 67203, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas 66720, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas 67801, United States

Cancer Center of Kansas - Kingman, Kingman, Kansas 67068, United States

Cancer Center of Kansas - Newton, Newton, Kansas 67114, United States

Cancer Center of Kansas - Salina, Salina, Kansas 67042, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas 67152, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas 67156, United States

Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas 67214, United States

Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas 67042, United States

Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas 67357, United States

Cancer Center of Kansas, P.A., Wichita, Kansas 67208, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Pratt Cancer Center of Kansas, Pratt, Kansas 67124, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48100, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48532, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan 49431, United States

Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan 49801, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan 48601, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48909, United States

St. John Macomb Hospital, Warren, Michigan 48903, United States

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan 48106-0995, United States

Adult and Pediatric Urology, P.L.L.P., St. Cloud, Minnesota 56303, United States

Brainerd Medical Center, Brainerd, Minnesota 56401, United States

Cancer Care Center at Regions Hospital, Saint Paul, Minnesota 55101, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CentraCare Clinic - River Campus, St. Cloud, Minnesota 56303, United States

Chippewa County - Montevideo Hospital, Montevideo, Minnesota 56265, United States

Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States

Fairview Southdale Hospital, Edina, Minnesota 55435, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota 55415, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota 55422, United States

Hutchinson Area Health Care, Hutchinson, Minnesota 55350, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Meeker County Memorial Hospital, Litchfield, Minnesota 55355, United States

Mercy and Unity Cancer Center at Mercy and Unity Hospitals, Fridley, Minnesota 55432, United States

Mercy Hospital, Coon Rapids, Minnesota 55433, United States

MeritCare Clinic - Bemidji, Bemidji, Minnesota 56601, United States

Park Nicollet Clinic, St. Louis Park, Minnesota 55416, United States

Ridgeview Medical Center, Waconia, Minnesota 55387, United States

Saint Francis Cancer Center, Shakopee, Minnesota 55379, United States

St. Cloud Hospital, Saint Cloud, Minnesota 56303, United States

St. John's Hospital, Maplewood, Minnesota 55109, United States

St. Joseph's Hospital, St Paul, Minnesota 55102, United States

St. Joseph's Medical Center, Brainerd, Minnesota 56401, United States

United Hospital, St. Paul, Minnesota 55102, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota 55407, United States

Woodwinds Hospital, Woodbury, Minnesota 55125, United States

Bozeman Deaconess Hospital, Bozeman, Montana 59715, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

Community Medical Center, Missoula, Montana 59801, United States

Deaconess Billings Clinic - Downtown, Billings, Montana 59101, United States

Deaconess Billings Clinic Cancer Center, Billings, Montana 59107, United States

Eastern Montana Cancer Center, Miles City, Montana 59301, United States

Great Falls Clinic, Great Falls, Montana 59405, United States

Kalispell Regional Medical Center, Kalispell, Montana 59901, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59802, United States

Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States

Sletten Regional Cancer Institute, Great Falls, Montana 59405, United States

St. James Community Hospital, Butte, Montana 59701, United States

St. Peter's Hospital, Helena, Montana 59601, United States

St. Vincent Healthcare, Billings, Montana 59101, United States

Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Bryan LGH Medical Center West, Lincoln, Nebraska 68502, United States

Cancer Center at Creighton University Medical Center, Omaha, Nebraska 68131, United States

Cancer Resource Center - Lincoln, Lincoln, Nebraska 68510, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Fremont Area Medical Center, Fremont, Nebraska 68025, United States

Immanuel Medical Center, Omaha, Nebraska 68122, United States

Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska 68046, United States

St. Elizabeth Regional Medical Center, Lincoln, Nebraska 68510, United States

Rutherford Hospital, Rutherfordton, North Carolina 28139, United States

Bismarck Cancer Center, Bismarck, North Dakota 58501, United States

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States

Medcenter One Health System, Bismarck, North Dakota 58501, United States

MeritCare Medical Group, Fargo, North Dakota 58122, United States

Mid Dakota Clinic, P.C., Bismarck, North Dakota 58501, United States

St. Alexius Medical Center, Bismarck, North Dakota 58501, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio 45429, United States

Good Samaritan Hospital, Dayton, Ohio 45406, United States

Grandview Hospital, Dayton, Ohio 45405, United States

Middletown Regional Hospital, Middletown, Ohio 45044, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio 45385, United States

Samaritan North Cancer Care Center, Dayton, Ohio 45415, United States

United States Air Force Medical Center Wright-Patterson, Wright-Patterson Afb, Ohio 45433-5529, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio 45373, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

Guthrie Medical Center - Sayre, Sayre, Pennsylvania 18840, United States

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania 18105, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29304, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina 29621, United States

Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, Sioux Falls, South Dakota 57105, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota 57104, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin 54154, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin 54303, United States

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin 54301-3526, United States

St. Mary's Hospital Medical Center, Green Bay, Wisconsin 54303, United States

St. Vincent Hospital, Green Bay, Wisconsin 54301, United States

Welch Cancer Center, Sheridan, Wyoming 82801, United States

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

Starting date: November 2004
Last updated: May 23, 2008