Fatigue Clinical Trial
Official title:
Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study
RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known
whether methylphenidate is more effective than a placebo in relieving fatigue and improving
quality of life in patients with cancer.
PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it
works in treating patients with fatigue caused by cancer.
Status | Completed |
Enrollment | 148 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. = 18 years of age 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: 1. Hypersensitivity to methylphenidate 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Billings Clinic - Downtown | Billings | Montana |
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 | 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 | St. Joseph Medical Center | Bloomington | Illinois |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Graham Hospital | Canton | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | CCOP - Colorado Cancer Research Program | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | St. Anthony Central Hospital | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | 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 | Mercy Capitol Hospital | Des Moines | Iowa |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Central Wisconsin Cancer Program at Agnesian HealthCare | Fond du Lac | Wisconsin |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota |
United States | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado |
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 | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | 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 | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Mason District Hospital | Havana | Illinois |
United States | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania |
United States | St. Peter's Hospital | Helena | Montana |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
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 | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland | Washington |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Cancer Resource Center - Lincoln | Lincoln | Nebraska |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
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 | McDonough District Hospital | Macomb | Illinois |
United States | Immanuel St. Joseph's | Mankato | Minnesota |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | St. Luke's Hospital | Maumee | Ohio |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Olympic Medical Center | Port Angeles | Washington |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Adventist Medical Center | Portland | Oregon |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | 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 | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Southlake Clinic | Renton | Washington |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
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 | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | North Coast Cancer Care, Incorporated | Sandusky | Ohio |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
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 | 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 | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | St. Margaret's Hospital | Spring Valley | Illinois |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Mercy Medical Center | Springfield | Ohio |
United States | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
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 | 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 | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
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 f — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4 | The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following: For those completed 4 weeks item: AUC/4; For those completed up to week 3 item: (AUC * 4) / 3; For those completed up to week 2 item: AUC * 2; For those completed up to week 1 item: AUC * 4; The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis. |
Baseline to week 4 | No |
Secondary | Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4 | The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4. | Baseline and Week 4 | Yes |
Secondary | AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4 | Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. | Baseline to Week 4 | No |
Secondary | AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4 | The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. | Baseline to Week 4 | No |
Secondary | AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4 | Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. | Baseline to Week 4 | No |
Secondary | AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4 | Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. | Baseline to Week 4 | No |
Secondary | Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue | Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms). | Baseline and Week 4 | No |
Secondary | Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue | Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms). | Baseline and Week 4 | No |
Secondary | Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue | Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms). | Baseline and Week 4 | No |
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