Spots Global Cancer Trial Database for Pregabalin in Treating Women With Hot Flashes
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Trial Identification
Brief Title: Pregabalin in Treating Women With Hot Flashes
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes
Study ID: NCT00702949
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Anthony Central Hospital, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
, Fergus Falls, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Immanuel St. Joseph's, Mankato, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research, Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Broadway, Fargo, North Dakota, United States
Mary Rutan Hospital, Bellefontaine, Ohio, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
St. Luke's Hospital, Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Adventist Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Mercy Hospital at Wilkes-Barre, Wilkes-Barre, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Central Wisconsin Cancer Program at Agnesian HealthCare, Fond du Lac, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Charles Loprinzi, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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