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Pregabalin in Treating Women With Hot Flashes

1 juillet 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

207

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Pregabalin75
Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
Médicament: pregabalin
Given orally
Expérimental: Pregabalin150
Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
Médicament: pregabalin
Given orally
Comparateur placebo: Placebo
Patients receive oral placebo twice daily for 6 weeks.
Autre: placebo
Donné oralement

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Délai: 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).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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 .
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Alliance for Clinical Trials in Oncology

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chaise d'étude: Charles Loprinzi, MD, Mayo Clinic

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2008

Achèvement primaire (Réel)

1 février 2010

Achèvement de l'étude (Réel)

1 mars 2015

Dates d'inscription aux études

Première soumission

19 juin 2008

Première soumission répondant aux critères de contrôle qualité

19 juin 2008

Première publication (Estimation)

20 juin 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 août 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2016

Dernière vérification

1 juillet 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCCTG-N07C1
  • NCI-2012-02716 (Identificateur de registre: CTRP (Clinical Trials Reporting System))
  • CDR0000598191 (Identificateur de registre: PDQ (Physician Data Query))

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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