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Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes


OBJECTIVES:

Primary

- Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash
scores in postmenopausal women with a history of breast cancer or in postmenopausal
women who do not wish to take estrogen replacement therapy for fear of increased risk
of breast cancer.

Secondary

- Compare the side effect profile of these regimens in these patients.

- Compare the effects of these regimens on the secondary outcome of mood and interference
with activities from hot flashes.

- Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of
citalopram hydrobromide.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to age (18-49 years vs ≥ 50 years), tamoxifen (yes vs no),
selective estrogen-receptor modulators (SERMs) (yes vs no), aromatase inhibitors (yes vs
no), duration of hot flashes (< 9 months vs ≥ 9 months), and frequency of hot flashes per
day (< 4 vs 4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.

- Arm I (low-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram
once daily in weeks 2-7.

- Arm II (medium-dose citalopram hydrobromide): Patients receive 1 tablet of oral
citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7.

- Arm III (high-dose citalopram hydrobromide): Patients receive 1 tablet of oral
citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once
daily in weeks 4-7.

- Arm IV (placebo): Patients receive 1-3 placebo tablets once daily in weeks 2-7. All
patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood
collection periodically during study treatment for translational research studies.

A Symptom Experience diary is completed weekly and Profile of Mood States and Hot
Flash-Related Interference Scale questionnaires are completed at baseline and in week 7.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Must meet 1 of the following criteria:

- History of breast cancer

- No current malignant disease

- No history of breast cancer and refused estrogen replacement therapy due to
perceived increased risk of breast cancer

- Bothersome hot flashes, defined as hot flashes ≥ 14 times/week and of sufficient
severity to make the patient desire therapeutic intervention

- Presence of hot flashes ≥ 1 month prior to study entry

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Postmenopausal, as defined by 1 of the following criteria:

- Absence of a menstrual period in the past 12 months

- Bilateral oophorectomy

- Absence of a menstrual period in the past 6 months with follicle-stimulating
hormone (FSH) level > 40 mIU/mL

- ECOG performance status 0-1

- Life expectancy ≥ 6 months

- Willing to provide blood samples during study participation

- No history of allergic or other adverse reactions to citalopram hydrobromide or other
selective serotonin reuptake inhibitors (SSRIs)

- No documented mania or hypomania

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior and no concurrent antineoplastic chemotherapy

- At least 4 weeks since prior and no concurrent androgens, estrogens, or
progestational agents

- At least 3 months since prior antidepressant use, including Hypericum perforatum (St.
John's wort)

- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed if on a constant
dose for ≥ 4 weeks and continuing medication during study period

- No other concurrent or planned agents for treating hot flashes (e.g., phenobarbital,
megestrol, or clonidine)

- Stable dose of vitamin E allowed as long as it was started > 30 days prior to
study entry

- Concurrent soy allowed

- Concurrent gabapentin allowed for reasons other than hot flashes if on a constant
dose for ≥ 1 month and continuing during study period

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Difference in average hot flash score from baseline until week 7 of treatment

Principal Investigator

Debra Barton, RN, PhD, AOCN, FAAN

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000489567

NCT ID:

NCT00363909

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • hot flashes
  • breast cancer
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
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
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
John Stoddard Cancer CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Great Falls ClinicGreat Falls, Montana  59405
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Elkhart General HospitalElkhart, Indiana  46515
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
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
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
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
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
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
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Resource Center - LincolnLincoln, Nebraska  68510
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower Hospital Cancer CenterSylvania, Ohio  43560
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Immanuel St. Joseph's ClinicMankato, Minnesota  56002
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Arch Medical Services, Incorporated at Center for Cancer Care ResearchSaint Louis, Missouri  63141
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
AnMed Cancer CenterAnderson, South Carolina  29621
Minnesota Oncology Hematology, PA at Maplewood Cancer CenterMaplewood, Minnesota  55109
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Hematology-Oncology Associates of Fredericksburg, IncorporatedFredericksburg, Virginia  22401
Central Wisconsin Cancer Program at Agnesian HealthCareFond du Lac, Wisconsin  54935