Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00880191
First received: April 10, 2009
Last updated: February 5, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Drug: dexamethasone
Drug: gabapentin
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of percentage of complete responders, with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6 [ Designated as safety issue: No ]
  • Complete response, defined as no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents [ Designated as safety issue: No ]
  • Comparison of percentages of complete responders on day 1, vs days 1 through 6 vs days 2 through 6 [ Designated as safety issue: No ]
  • Comparison of the proportion of patients experiencing emetic episodes and the proportion needing rescue agents [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Comparison fo sum of the daily distress questions as well as the individual daily responses [ Designated as safety issue: No ]
  • Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary as well as the nausea subscale on the Functional Living Index - Emesis questionnaire [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of daily complete response endpoints [ Designated as safety issue: No ]

Estimated Enrollment: 416
Study Start Date: April 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: dexamethasone
Given orally
Drug: gabapentin
Given orally
Experimental: 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.
Drug: dexamethasone
Given orally
Other: placebo
Given orally

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880191

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
St. Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
Rose Medical Center
Denver, Colorado, United States, 80220
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Graham Hospital
Canton, Illinois, United States, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
McDonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States, 49120
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Alexandria, Minnesota, United States, 56308
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Fergus Falls Medical Group, PA
Fergus Falls, Minnesota, United States, 56537
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Comprehensive Cancer Care, PC
Saint Louis, Missouri, United States, 63141
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
MeritCare Broadway
Fargo, North Dakota, United States, 58122
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
North Coast Cancer Care - Clyde
Clyde, Ohio, United States, 43410
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
CCOP - Dayton
Dayton, Ohio, United States, 45420
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00880191     History of Changes
Other Study ID Numbers: CDR0000634077, NCCTG-N08C3
Study First Received: April 10, 2009
Last Updated: February 5, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
nausea and vomiting
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Gabapentin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anticonvulsants
Antiparkinson Agents

ClinicalTrials.gov processed this record on April 23, 2014