Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional supportive care trial for Nausea and Vomiting focused on measuring nausea and vomiting, unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS:
Scheduled to receive highly emetogenic chemotherapy
- May be scheduled to receive prophylactic treatment for acute nausea and vomiting with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy treatment
- May be scheduled to receive multiple day chemotherapy regimens as long as the chemotherapy drugs given on the subsequent days have mild or no emetogenic potential
- Chemotherapy schedules must allow at least 7 days rest between courses involving administration of highly emetogenic chemotherapy
- No primary CNS malignancy and/or CNS metastasis
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 3 months
- Creatinine ≤ 1.5 times upper limit of normal within the past 30 days
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ability to complete questionnaire(s) by his/herself or with assistance
- Able to swallow pills
- No epilepsy or seizure history
- No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled heartburn
- No history of nausea and/or vomiting related to any kind of chemotherapy
- No nausea or vomiting within the past 3 days
- No history of allergic or other adverse reaction to gabapentin or pregabalin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior moderate or highly emetogenic chemotherapy
- No prior or concurrent aprepitant or any other NK-1 receptor antagonist
- At least 1 months since prior and no concurrent gabapentin, pregabalin, or other anticonvulsants
- At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy
- At least 3 days since prior antiemetics
- No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or dronabinol during the 6 days of this study, except for treatment of breakthrough nausea and vomiting
Sites / Locations
- Mayo Clinic Scottsdale
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Mayo Clinic - Jacksonville
- MBCCOP - Medical College of Georgia Cancer Center
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Illinois CancerCare - Spring Valley
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- South Bend Clinic
- Michiana Hematology Oncology PC - La Porte
- McFarland Clinic, PC
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Michiana Hematology Oncology PC - Niles
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeside Cancer Specialists, PLLC
- Lakeland Regional Cancer Care Center - St. Joseph
- St. John Macomb Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Fergus Falls Medical Group, PA
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Immanuel St. Joseph's
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Regions Hospital Cancer Care Center
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- Comprehensive Cancer Care, PC
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Lovelace Medical Center - Downtown
- University of New Mexico Cancer Center
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Altru Cancer Center at Altru Hospital
- Mary Rutan Hospital
- Wood County Oncology Center
- Adena Regional Medical Center
- North Coast Cancer Care - Clyde
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Clinton Memorial Hospital
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Fredericksburg Oncology, Incorporated
- Virginia Commonwealth University Massey Cancer Center
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Lakeland Center
- Green Bay Oncology, Limited - Oconto Falls
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic at Saint Michael's Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
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.
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.