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Spots Global Cancer Trial Database for Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
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Trial Identification

Brief Title: Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Official Title: Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

Study ID: NCT00343382

Study Description

Brief Summary: RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer. PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

Detailed Description: OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs \> 65), concurrent tamoxifen therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), concurrent aromatase inhibitor therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below. OBJECTIVES: Primary * Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer. Secondary * Evaluate any toxicities arising from pilocarpine hydrochloride in these patients. * Evaluate quality of life of these patients treated with pilocarpine hydrochloride. Quality of life was assessed at baseline and then weekly for 6 weeks.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

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

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States

McDonough District Hospital, Macomb, Illinois, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States

, Moline, Illinois, United States

OSF Holy Family Medical Center, Monmouth, 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

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

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

McFarland Clinic, PC, Ames, Iowa, United States

, Bettendorf, Iowa, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States

Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, 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

Lawrence Memorial Hospital, Lawrence, 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

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States

Mecosta County Medical Center, Big Rapids, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Foote Memorial Hospital, Jackson, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary Mercy Hospital, Livonia, Michigan, United States

Mercy General Health Partners, Muskegon, 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

Munson Medical Center, Traverse City, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

Metro Health Hospital, Wyoming, Michigan, United States

, Alexandria, Minnesota, 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

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States

CCOP - Duluth, Duluth, Minnesota, United States

Miller - Dwan Medical Center, Duluth, 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

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Meeker County Memorial Hospital, Lichfield, Minnesota, United States

Immanuel St. Joseph's, Mankato, Minnesota, United States

HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center - Minneapolis, 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

St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States

Regions Hospital Cancer Care Center, St. Paul, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, 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

St. James Healthcare Cancer Care, Butte, Montana, United States

Big Sky Oncology, Great Falls, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, 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

Immanuel Medical Center, Omaha, Nebraska, United States

Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

MeritCare Broadway, Fargo, North Dakota, United States

Mary Rutan Hospital, Bellefontaine, 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

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States

Mercy Medical Center, Springfield, Ohio, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio, United States

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States

Providence Milwaukie Hospital, Milwaukie, 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 Meridian Park Hospital, Tualatin, Oregon, United States

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States

AnMed Cancer Center, Anderson, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, 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

Virginia Commonwealth University Massey Cancer Center, Richmond, 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

Contact Details

Name: Charles L. Loprinzi, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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