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
Not Enrolling
Female
Breast Cancer, Hot Flashes

Thank you

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