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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 - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Fairview Southdale HospitalEdina, Minnesota  55435
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
Great Falls ClinicGreat Falls, Montana  59405
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Welch Cancer CenterSheridan, Wyoming  82801
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Medcenter One Health SystemBismarck, North Dakota  58501
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Trinity Medical Center - EastMoline, Illinois  61265
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Luke's HospitalCedar Rapids, Iowa  52402
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Immanuel Medical CenterOmaha, Nebraska  68122
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
MeritCare Medical GroupFargo, North Dakota  58122
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Eureka HospitalEureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Mercy HospitalCoon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Mercy and Unity HospitalsFridley, Minnesota  55432-2799
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
McFarland Clinic, P.C.Ames, Iowa  50010
Saint Anthony Regional HospitalCarroll, Iowa  51401
St. John's HospitalMaplewood, Minnesota  55109
St. Cloud HospitalSaint Cloud, Minnesota  56303
Fremont Area Medical CenterFremont, Nebraska  68025-2387
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Mercy Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Alegent Health Community Memorial HospitalMissouri Valley, Iowa  51555
Cancer Care Center at Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Adult and Pediatric Urology, P.L.L.P.St. Cloud, Minnesota  56303
Woodwinds HospitalWoodbury, Minnesota  55125
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Cancer Center at Creighton University Medical CenterOmaha, Nebraska  68131
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
Guthrie Medical Center - SayreSayre, Pennsylvania  18840
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529
Cancer Center at Ottumwa Regional Health CenterOttumwa, Iowa  52501