Spots Global Cancer Trial Database for Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
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Trial Identification
Brief Title: Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Official Title: Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy
Study ID: NCT00880191
Study Description
Brief Summary: RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in preventing nausea and vomiting. PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to see how well it works compared with a placebo in preventing nausea and vomiting in patients receiving chemotherapy.
Detailed Description: OBJECTIVES: * To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes and no rescue medication) on days 2 through 6 (five days after receipt of highly emetogenic chemotherapy) compared to an effective prophylactic regimen. * To evaluate the effectiveness of gabapentin in controlling delayed CINV in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes, no more than mild nausea, and no rescue medication) on days 2 through 6 compared to an effective prophylactic regimen. * To compare the effectiveness of these regimens in controlling acute CINV on day 1 of treatment in these patients. * To compare the use of rescue agents in these patients. * To determine the tolerability of gabapentin in these patients. * To evaluate the effect of gabapentin for delayed chemotherapy-induced nausea and vomiting on symptom distress and functional abilities in these patients. * To compare alternative endpoints and methods for assessing nausea and vomiting and to determine how these measures compare to patient's satisfaction with symptom control, distress and function. OUTLINE: This is a multicenter study. Patients are stratified according to gender, age (\< 50 years vs \> 50 years), history of alcoholism (yes vs no), and history of motion sickness or history of pregnancy induced nausea/vomiting (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy. * Arm II: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy. Patients complete a Functional Living Index - Emesis questionnaire, an overall satisfaction survey, and a side effect experience diary at baseline and on day 6. Patients also complete a nausea and vomiting diary at baseline and periodically during study therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, 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
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Illinois CancerCare - Bloomington, Bloomington%, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
Illinois CancerCare - Havana, Havana, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare - Macomb, Macomb, 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
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare - 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
Illinois CancerCare - Pekin, 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 CancerCare - Peru, Peru, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Illinois CancerCare - Princeton, Princeton, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Illinois CancerCare - Spring Valley, Spring Valley, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, 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
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
, Bettendorf, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, 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
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 - Fort Scott, Fort Scott, 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
Cancer Center of Kansas, PA - Liberal, 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
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
Michiana Hematology Oncology PC - Niles, Niles, 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
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
St. John Macomb Hospital, Warren, 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 Medical Group, PA, 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
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
Willmar Cancer Center at Rice Memorial Hospital, Willmar, 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
Comprehensive Cancer Care, PC, Saint Louis, Missouri, 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
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Rutherford Hospital, Rutherfordton, North Carolina, 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
Altru Cancer Center at Altru Hospital, Grand Forks, 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
North Coast Cancer Care - Clyde, Clyde, 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
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Cancer Center, Elyria, Ohio, United States
Hematology Oncology Center, Elyria, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, 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
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Fisher-Titus Medical Center, Norwalk, 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
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
St. Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, 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
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
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Marshfield Clinic - Chippewa Center, Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, 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
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Debra Barton, RN, PhD, AOCN, FAAN
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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