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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes
Female
Breast Cancer, Hot Flashes
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Hot flash reduction by diary record at 4 weeks
Principal Investigator
Charles L. Loprinzi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000374993
NCT ID:
NCT00087399
Start Date:
November 2004
Completion Date:
Related Keywords:
- Breast Cancer
- Hot Flashes
- breast cancer
- hot flashes
- Breast Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
| Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
| Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
| Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
| Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
| Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
| Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
| Associates in Womens Health | Wichita, Kansas 67203 |
| Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
| Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
| Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| Trinity Medical Center - East | Moline, Illinois 61265 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Valley Cancer Center | Spring Valley, Illinois 61362 |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Burgess Health Center | Onawa, Iowa 51040 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
| MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
| Brainerd Medical Center | Brainerd, Minnesota 56401 |
| St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
| St. Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center | Bismarck, North Dakota 58502 |
| MeritCare Medical Group | Fargo, North Dakota 58122 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
| Eureka Hospital | Eureka, Illinois 61530 |
| Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
| Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Mercy and Unity Cancer Center at Mercy and Unity Hospitals | Fridley, Minnesota 55432-2799 |
| Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| McFarland Clinic, P.C. | Ames, Iowa 50010 |
| Saint Anthony Regional Hospital | Carroll, Iowa 51401 |
| St. John's Hospital | Maplewood, Minnesota 55109 |
| St. Cloud Hospital | Saint Cloud, Minnesota 56303 |
| Fremont Area Medical Center | Fremont, Nebraska 68025-2387 |
| Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Mercy Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| Alegent Health Mercy Hospital | Council Bluffs, Iowa 51503 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Alegent Health Community Memorial Hospital | Missouri Valley, Iowa 51555 |
| Cancer Care Center at Regions Hospital | Saint Paul, Minnesota 55101 |
| Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
| St. Joseph's Hospital | St Paul, Minnesota 55102 |
| Adult and Pediatric Urology, P.L.L.P. | St. Cloud, Minnesota 56303 |
| Woodwinds Hospital | Woodbury, Minnesota 55125 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Cancer Center at Creighton University Medical Center | Omaha, Nebraska 68131 |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
| Guthrie Medical Center - Sayre | Sayre, Pennsylvania 18840 |
| St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| United States Air Force Medical Center Wright-Patterson | Wright-Patterson Afb, Ohio 45433-5529 |
| Cancer Center at Ottumwa Regional Health Center | Ottumwa, Iowa 52501 |
