Levocarnitine in Treating Fatigue in Cancer Patients - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091169

Purpose

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.

Condition	Intervention	Phase
Fatigue Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: levocarnitine Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements

Drug Information available for: Carnitine

U.S. FDA Resources

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

Primary Outcome Measures:

Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevalence of carnitine deficiency [ Designated as safety issue: No ]
Changes in levels of fatigue [ Designated as safety issue: No ]
Effect on pain and performance status at 4 and 8 weeks [ Designated as safety issue: No ]
Score changes in the BFI and the Brief Pain Inventory [ Designated as safety issue: No ]
Survival [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: No ]

Estimated Enrollment:	352
Study Start Date:	November 2005
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.	Dietary Supplement: levocarnitine Given orally
Arm II: Placebo Comparator Patients receive oral placebo twice daily on weeks 1-4.	Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.

Secondary

Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.
Assess changes in the levels of fatigue at its worst.
Assess the effect of levocarnitine on pain and performance status at 4 and 8 weeks of follow-up.
Assess score changes in the items of the Brief Fatigue Inventory and the Brief Pain Inventory.
Explore the association between carnitine (and acetyl levocarnitine) deficiency and fatigue and other selected covariates.
Present the toxicity profiles of all patients.
Measure serum levels of the pro-inflammatory cytokines IL-1, IL-6, TNF-α, the growth factors TGF-α, EGF, NRG-1, VEGF, and triglycerides (TG) and correlate with fatigue and other oncobehavioral symptoms.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, ECOG performance status (0-1 vs 2-3), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
Arm II: Patients receive oral placebo twice daily on weeks 1-4. After week 4, all patients receive oral L-carnitine twice daily on weeks 5-8.

Fatigue is assessed at baseline and then at weeks 4 and 8.

PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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 FACIT-F question "I feel fatigued"
No brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 9 g/dL

Hepatic

No severe, uncontrolled liver disease

Renal

No evidence of severely compromised renal function including any 1 of the following:
- Renal failure
- End stage renal disease
- Ongoing renal dialysis

Cardiovascular

No severe, uncontrolled cardiovascular disease

Pulmonary

No severe, uncontrolled pulmonary disease

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
No history of seizures
No known sensitivity to carnitine
No delirium
No nausea > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

More than 2 months since prior levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091169

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Locations

United States, California
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
United States, Connecticut
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States, 33486
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
United States, Michigan
St. John Macomb Hospital
Warren, Michigan, United States, 48093
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Hospital
Jackson, Michigan, United States, 49201
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55416
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Beth Israel Medical Center - Petrie Division
New York, New York, United States, 10003-3803
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Jennersville Regional Hospital
West Grove, Pennsylvania, United States, 19390-9499
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Dean Medical Center - Madison
Madison, Wisconsin, United States, 53717
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
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

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Ricardo Cruciani, MD, PhD	Beth Israel Medical Center - Petrie Division
Investigator:	Russell K. Portenoy, MD	Beth Israel Medical Center - Petrie Division

Responsible Party:	Coalition of National Cancer Cooperative Groups ( Robert L. Comis )
Study ID Numbers:	CDR0000384087, ECOG-E4Z02
Study First Received:	September 7, 2004
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00091169 History of Changes
Health Authority:	United States: Federal Government