Fatigue Clinical Trial
Official title:
Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Levocarnitine may help improve energy levels in cancer patients. PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients.
Status | Completed |
Enrollment | 376 |
Est. completion date | May 2011 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of an invasive malignant disorder - Moderate to severe fatigue within the past 4 weeks, defined as a score of = 2 (on a scale of 0-4) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) question "I feel fatigued" - Age 18 and over - Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3 - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation Exclusion Criteria: - Brain metastases - Hemoglobin < 9 g/dL, taken <=4 weeks prior to registration - Severe, uncontrolled liver disease - Evidence of severely compromised renal function including any 1 of the following: - Renal failure - End stage renal disease - Ongoing renal dialysis - Severe, uncontrolled cardiovascular disease - Severe, uncontrolled pulmonary disease - Pregnant or nursing - History of seizures - Known sensitivity to carnitine - Delirium - Nausea > grade 1 - Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration |
Country | Name | City | State |
---|---|---|---|
United States | Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton | Florida |
United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
United States | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Graham Hospital | Canton | Illinois |
United States | Mercy Cancer Center at Mercy Medical Center | Canton | Ohio |
United States | Memorial Hospital | Carthage | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
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 | Praxair Cancer Center at Danbury Hospital | Danbury | Connecticut |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
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 | 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 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Mason District Hospital | Havana | Illinois |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Foote Hospital | Jackson | Michigan |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Lewistown Hospital | Lewistown | Pennsylvania |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | McDonough District Hospital | Macomb | Illinois |
United States | Dean Medical Center - Madison | Madison | Wisconsin |
United States | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin |
United States | Manchester Memorial Hospital | Manchester | Connecticut |
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 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Beth Israel Medical Center - Petrie Division | New York | New York |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
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 | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa |
United States | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California |
United States | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania |
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 | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Seton Cancer Institute - Saginaw | Saginaw | Michigan |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
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 | 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 | 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 | 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 | Stanford Comprehensive Cancer Center - Stanford | Stanford | California |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Mount Nittany Medical Center | State College | Pennsylvania |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
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 | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Jennersville Regional Hospital | West Grove | Pennsylvania |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania |
United States | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
ECOG-ACRIN Cancer Research Group | National Cancer Institute (NCI) |
United States,
Cruciani RA, Zhang JJ, Manola J, Cella D, Ansari B, Fisch MJ. L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial. J Clin On — View Citation
Rich TA, Fisch MJ, Manola J, et al.: Analysis of cytokines in ECOG E4Z02: A phase III randomized study of l-carnitine supplementation for fatigue in patients with cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-9635, 2009.
Rich TA, Manola J, Cella D, et al.: An evaluation of serum cytokine levels and fatigue and depression in ECOG E4Z02. [Abstract] J Clin Oncol 29 (Suppl 15): A-9046, 2011.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks | Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline. | assessed at baseline and 4 weeks after randomization | |
Secondary | Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks | Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline. | assessed at baseline and 4 weeks after randomization | |
Secondary | Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline | Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline. | assessed at baseline and 4 weeks after randomization | |
Secondary | Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks | Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline. | assessed at baseline and 4 weeks after randomization | |
Secondary | Prevalence of Carnitine Deficiency at 4 Weeks | Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 µmol/L or free carnitine < 35 µmol/L for males and < 25 µmol/L for females. | assessed at 4 weeks after randomization | |
Secondary | Proportion of Patients With Stable or Improving Performance Status at 4 Weeks | Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS. | assessed at baseline and 4 weeks after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04959214 -
The Effect Of Progressıve Relaxatıon Exercıses
|
N/A | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Completed |
NCT04531891 -
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT04960865 -
Kinesio Taping and Calf Muscle Fatigue
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A | |
Active, not recruiting |
NCT05344183 -
Immediate and Short-term Effects of Low-level Laser
|
N/A | |
Completed |
NCT04716049 -
Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players
|
N/A | |
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05241405 -
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
|
N/A | |
Active, not recruiting |
NCT06074627 -
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
|
N/A | |
Completed |
NCT03943212 -
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
|
N/A | |
Recruiting |
NCT05567653 -
Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers
|
N/A | |
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT05863897 -
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
|
N/A | |
Not yet recruiting |
NCT05002894 -
Effect of Pilates Exercises On Fatigue In Post Menopausal Women
|
N/A | |
Recruiting |
NCT04091789 -
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|
Phase 2 | |
Completed |
NCT02911649 -
Reducing Sedentary Behaviour With Technology
|
N/A | |
Completed |
NCT03216616 -
Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
|
N/A |