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
Recruitment status was Active, not recruiting
Sponsor:
North Central Cancer Treatment Group
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
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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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Gabapentin
Gabapentin enacarbil
U.S. FDA Resources
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
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| 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 May 16, 2013