Methylphenidate in Treating Patients With Fatigue Caused by Cancer
NCT ID: NCT00376675
Last Updated: 2016-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2008-02-29
2010-06-30
Brief Summary
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PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.
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Detailed Description
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Primary
* Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory.
Secondary
* Evaluate the tolerability and adverse events associated with this drug in these patients.
* Study the effect of this drug on quality of life (QOL)-related variables (vitality, sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived treatment efficacy) in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral methylphenidate daily on days 1-28.
* Arm II: Patients receive oral placebo daily on days 1-28.
Patients in both arms complete questionnaires to assess their symptoms of fatigue, overall mood, quality of life, sleep quality, and adverse effects from treatment at baseline and once weekly for 4 weeks. Patients also complete a Symptom Experience Diary.
McNeil Consumer \& Specialty Pharmaceuticals provided medication support for NCCTG N05C7.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I
Patients receive oral methylphenidate hydrochloride daily on days 1-28.
methylphenidate hydrochloride
Given orally
Arm II
Patients receive oral placebo daily on days 1-28.
placebo
Given orally
Interventions
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methylphenidate hydrochloride
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
2. Men or women with a history of cancer-related fatigue as defined by a score ≥ 4 on a fatigue numerical analogue scale (0 - 10)
3. Fatigue for ≥ 1 month prior to registration
4. ECOG Performance Score (PS) 0, 1, or 2
5. Life expectancy ≥ 6 months
6. Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma
7. Laboratory values obtained ≤ 30 days prior to registration:
* Hgb ≥ 10 g/dL
8. Willing and able to provide informed consent
9. Negative pregnancy test (urine or serum) done ≤ 7 days prior to registration, for women of childbearing potential only
10. Ability to complete questionnaire(s) by themselves or with assistance
11. Biological therapy (i.e. immunotherapy, biotherapy), chemotherapy or radiation therapy will be allowed
12. Use of a stable dose of anti-depressants (except tricyclic anti-depressants) will be allowed
13. Erythropoietic agents to treat anemia, and steroids as a part of cancer treatment and for symptom management (except for fatigue) will be allowed
Exclusion Criteria
2. Any prior use of methylphenidate
3. Concomitant (≤ 2 weeks) use of prescription stimulants (pemoline, modafinil, amphetamines); other medications, herbal products or dietary supplements for fatigue
4. Uncontrolled hypertension \[defined as systolic blood pressure (BP) ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on 2 separate visits ≤ 2 months prior to randomization\]; or a resting heart rate \> 100
5. Moderate or severe pain as defined by an average daily score ≥ 4 on a pain analog scale (0 - 10)
6. Known brain metastasis or primary CNS malignancy
7. Clinically significant acute or chronic progressive or unstable neurologic (dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or respiratory disease that would limit participation in the study per MD discretion or judgment
8. Psychiatric disorder such as manic depression, anxiety disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia
9. Major surgery \< 4 weeks prior to registration. (Note: Insertion of central venous catheter is not considered major surgery.)
10. Using a drug contraindicated when taken concurrently with methylphenidate: coumarin anticoagulants, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, and pseudoephedrine
Note: use of Compazine prescribed as an antiemetic is permitted for use while participating in this study.
11. Additional medical conditions where use of methylphenidate is contraindicated:
glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, history of drug or alcohol abuse or intestinal obstruction.
12. Pregnant women or nursing women. Women of childbearing potential who are unwilling to employ adequate contraception. This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown.
13. Untreated hypothyroidism (TSH ≥ 5)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
INDUSTRY
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Amit Sood, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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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
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
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
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Moline, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, 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 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
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
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Capitol Hospital
Des Moines, 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, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley 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
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, 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
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Immanuel St. Joseph's
Mankato, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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
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
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
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
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
Samaritan North Cancer Care Center
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, 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
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, 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
Mercy Medical Center
Springfield, 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
CCOP - Toledo Community 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
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
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Adventist Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Mercy Hospital at Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States
AnMed Cancer Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Southlake Clinic
Renton, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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References
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Moraska AR, Sood A, Dakhil SR, Sloan JA, Barton D, Atherton PJ, Suh JJ, Griffin PC, Johnson DB, Ali A, Silberstein PT, Duane SF, Loprinzi CL. Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial. J Clin Oncol. 2010 Aug 10;28(23):3673-9. doi: 10.1200/JCO.2010.28.1444. Epub 2010 Jul 12.
Other Identifiers
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NCI-2012-02701
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000495148
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N05C7
Identifier Type: -
Identifier Source: org_study_id
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