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Pregabalin in Treating Women With Hot Flashes

1. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes

RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes.

PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
To evaluate the side effect profile of different doses of pregabalin in these patients.
To evaluate the effect of 150 mg of pregabalin versus placebo on the secondary outcome of interference of activities from hot flashes in these patients.
To evaluate the efficacy and side effect profile of 75 mg of pregabalin versus placebo in these patients.

OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
Arm II: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
Arm III: Patients receive oral placebo twice daily for 6 weeks. Treatment in all arms continues in the absence of unacceptable toxicity.

Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.

Studietype

Intervensjonell

Registrering (Faktiske)

207

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Arizona
  - Scottsdale, Arizona, Forente stater, 85259-5499
    - Mayo Clinic Scottsdale
- Colorado
  - Aurora, Colorado, Forente stater, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, Forente stater, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, Forente stater, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, Forente stater, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, Forente stater, 80220
    - Rose Medical Center
  - Denver, Colorado, Forente stater, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, Forente stater, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, Forente stater, 80218
    - St. Joseph Hospital
  - Denver, Colorado, Forente stater, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, Forente stater, 80110
    - Swedish Medical Center
  - Grand Junction, Colorado, Forente stater, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, Forente stater, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, Forente stater, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, Forente stater, 80502
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, Forente stater, 80539
    - McKee Medical Center
  - Pueblo, Colorado, Forente stater, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, Forente stater, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, Forente stater, 80033
    - Exempla Lutheran Medical Center
- Florida
  - Jacksonville, Florida, Forente stater, 32224
    - Mayo Clinic - Jacksonville
- Illinois
  - Aurora, Illinois, Forente stater, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Forente stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forente stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forente stater, 62321
    - Memorial Hospital
  - Eureka, Illinois, Forente stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forente stater, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Forente stater, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, Forente stater, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Forente stater, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Forente stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Macomb, Illinois, Forente stater, 61455
    - Mcdonough District Hospital
  - Normal, Illinois, Forente stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forente stater, 61761
    - Community Cancer Center
  - Ottawa, Illinois, Forente stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forente stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forente stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Forente stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forente stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forente stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forente stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forente stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forente stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forente stater, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Forente stater, 61362
    - St. Margaret's Hospital
  - Urbana, Illinois, Forente stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forente stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Elkhart, Indiana, Forente stater, 46515
    - Elkhart General Hospital
  - Kokomo, Indiana, Forente stater, 46904
    - Howard Community Hospital
  - La Porte, Indiana, Forente stater, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, Forente stater, 46360
    - Saint Anthony Memorial Health Centers
  - South Bend, Indiana, Forente stater, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, Forente stater, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, Forente stater, 46617
    - Saint Joseph Regional Medical Center
  - South Bend, Indiana, Forente stater, 46617
    - South Bend Clinic
- Iowa
  - Cedar Rapids, Iowa, Forente stater, 52403
    - Cedar Rapids Oncology Associates
  - Des Moines, Iowa, Forente stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forente stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forente stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forente stater, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, Forente stater, 50307
    - Mercy Capitol Hospital
  - Ottumwa, Iowa, Forente stater, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, Forente stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forente stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forente stater, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Forente stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forente stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Independence, Kansas, Forente stater, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, Forente stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Forente stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forente stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forente stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forente stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Forente stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forente stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forente stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, Forente stater, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, Forente stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Adrian, Michigan, Forente stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, Forente stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, Forente stater, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, Forente stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forente stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forente stater, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, Forente stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, Forente stater, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, Forente stater, 49201
    - Foote Memorial Hospital
  - Lambertville, Michigan, Forente stater, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, Forente stater, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, Forente stater, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, Forente stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forente stater, 48162
    - Mercy Memorial Hospital - Monroe
  - Pontiac, Michigan, Forente stater, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, Forente stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, Forente stater, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - St. Joseph, Michigan, Forente stater, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, Forente stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Bemidji, Minnesota, Forente stater, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, Forente stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forente stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, Forente stater, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Forente stater, 56537
  - Fridley, Minnesota, Forente stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Mankato, Minnesota, Forente stater, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, Forente stater, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Minneapolis, Minnesota, Forente stater, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Robbinsdale, Minnesota, Forente stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, Forente stater, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, Forente stater, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Forente stater, 55102
    - United Hospital
  - Waconia, Minnesota, Forente stater, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Forente stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Missouri
  - Saint Louis, Missouri, Forente stater, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Forente stater, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care and Research
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forente stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forente stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forente stater, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Forente stater, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, Forente stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forente stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forente stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forente stater, 59405
  - Havre, Montana, Forente stater, 59501
    - Northern Montana Hospital
  - Helena, Montana, Forente stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forente stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Forente stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forente stater, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Forente stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forente stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Lincoln, Nebraska, Forente stater, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, Forente stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forente stater, 68131-2197
    - Creighton University Medical Center
- North Dakota
  - Bismarck, North Dakota, Forente stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forente stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forente stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forente stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Forente stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forente stater, 58122
    - MeritCare Broadway
- Ohio
  - Bellefontaine, Ohio, Forente stater, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, Forente stater, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, Forente stater, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, Forente stater, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, Forente stater, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, Forente stater, 43215
    - CCOP - Columbus
  - Columbus, Ohio, Forente stater, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, Forente stater, 43228
    - Doctors Hospital at Ohio Health
  - Delaware, Ohio, Forente stater, 43015
    - Grady Memorial Hospital
  - Lancaster, Ohio, Forente stater, 43130
    - Fairfield Medical Center
  - Lima, Ohio, Forente stater, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, Forente stater, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, Forente stater, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Forente stater, 43537
    - St. Luke's Hospital
  - Newark, Ohio, Forente stater, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, Forente stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forente stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forente stater, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, Forente stater, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, Forente stater, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, Forente stater, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Forente stater, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Forente stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forente stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forente stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forente stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forente stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Wauseon, Ohio, Forente stater, 43567
    - Fulton County Health Center
  - Westerville, Ohio, Forente stater, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Zanesville, Ohio, Forente stater, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Gresham, Oregon, Forente stater, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, Forente stater, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, Forente stater, 97216
    - Adventist Medical Center
  - Portland, Oregon, Forente stater, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Portland, Oregon, Forente stater, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, Forente stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forente stater, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, Forente stater, 97227
    - Legacy Emanuel Hospital and Health Center and Children's Hospital
  - Tualatin, Oregon, Forente stater, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Danville, Pennsylvania, Forente stater, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, Forente stater, 18201
    - Geisinger Hazleton Cancer Center
  - State College, Pennsylvania, Forente stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Forente stater, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wilkes-Barre, Pennsylvania, Forente stater, 18765
    - Mercy Hospital at Wilkes-Barre
- South Dakota
  - Rapid City, South Dakota, Forente stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Forente stater, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, Forente stater, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Vancouver, Washington, Forente stater, 98668
    - Southwest Washington Medical Center Cancer Center
- Wisconsin
  - Fond du Lac, Wisconsin, Forente stater, 54935
    - Central Wisconsin Cancer Program at Agnesian HealthCare
  - Green Bay, Wisconsin, Forente stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forente stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forente stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forente stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Marinette, Wisconsin, Forente stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Oconto Falls, Wisconsin, Forente stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Sturgeon Bay, Wisconsin, Forente stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
- Wyoming
  - Sheridan, Wyoming, Forente stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS:

Meeting 1 of the following criteria:
- History of breast cancer (currently without malignant disease)
- No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer
Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
Presence of hot flashes for ≥ 1 month prior to study entry

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥ 6 months
Able to complete questionnaire(s) by themselves or with assistance
Women of childbearing potential not eligible (per the judgment of the attending clinician)
Serum creatinine ≤ 1.5 times upper limit of normal

PRIOR CONCURRENT THERAPY:

No prior gabapentin or pregabalin
More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
- Vaginal estrogen is allowed if used for the past month and not planned to be discontinued
Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab [Herceptin®]) allowed in patients with no evidence of disease
Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period
No concurrent or planned use of other agents for hot flashes except for any of the following:
- Stable dose of vitamin E is allowed as long as agent was started > 30 days prior to study initiation and is to be continued throughout the study period
- Soy is allowed, if it is planned to be continued at the same dose during the study period
- Stable dose of antidepressants is allowed as long as it was started > 30 days prior to study initiation and is to be continued at a stable dose throughout the study period

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Støttende omsorg
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Pregabalin75 Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.	Legemiddel: pregabalin Given orally
Eksperimentell: Pregabalin150 Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.	Legemiddel: pregabalin Given orally
Placebo komparator: Placebo Patients receive oral placebo twice daily for 6 weeks.	Annen: placebo Gis muntlig

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment
Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment
Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment
Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment
Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). Tidsramme: Baseline, after week 6 of treatment	Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).	Baseline, after week 6 of treatment
Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . Tidsramme: Baseline, 6 weeks during treatment.	A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).	Baseline, 6 weeks during treatment.
Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment Tidsramme: Baseline, after week 6 of treatment.	Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.	Baseline, after week 6 of treatment.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Charles Loprinzi, MD, Mayo Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Loprinzi CL, Qin R, Stella PJ, et al.: Pregabalin for hot flashes in women: NCCTG trial N07C1. [Abstract] J Clin Oncol 27 (Suppl 15): A-9513, 2009.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2008

Primær fullføring (Faktiske)

1. februar 2010

Studiet fullført (Faktiske)

1. mars 2015

Datoer for studieregistrering

Først innsendt

19. juni 2008

Først innsendt som oppfylte QC-kriteriene

19. juni 2008

Først lagt ut (Anslag)

20. juni 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

NCCTG-N07C1
NCI-2012-02716 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
CDR0000598191 (Registeridentifikator: PDQ (Physician Data Query))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

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Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Brystkreft

Kliniske studier på placebo

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