Levocarnitine in Treating Fatigue in Cancer Patients

Condition(s) targeted: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: levocarnitine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Ricardo Cruciani, MD, PhD, Study Chair, Affiliation: Beth Israel Medical Center - Petrie Division
Russell K. Portenoy, MD, Affiliation: Beth Israel Medical Center - Petrie Division

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.

Official title: Phase III Randomized Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks

Secondary outcome:

Prevalence of carnitine deficiency

Changes in levels of fatigue

Effect on pain and performance status at 4 and 8 weeks

Score changes in the BFI and the Brief Pain Inventory

Survival

Toxicity

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.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Stanford Comprehensive Cancer Center - Stanford, Stanford, California 94305, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States

Manchester Memorial Hospital, Manchester, Connecticut 06040, United States

Praxair Cancer Center at Danbury Hospital, Danbury, Connecticut 06810, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center, Boca Raton, Florida 33486, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Eureka Community Hospital, Eureka, Illinois 61530, United States

Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States

Galesburg Clinic, PC, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Graham Hospital, Canton, Illinois 61520, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Mason District Hospital, Havana, Illinois 62644, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States

OSF St. Francis Medical Center, Peoria, Illinois 61637, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

St. Joseph Medical Center, Bloomington, Illinois 61701, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Howard Community Hospital, Kokomo, Indiana 46904, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States

McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa 52501, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Dickinson County Healthcare System, Iron Mountain, Michigan 49801, United States

Foote Hospital, Jackson, Michigan 49201, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan 49431, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan 48601, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States

St. John Macomb Hospital, Warren, Michigan 48093, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States

Fairview Southdale Hospital, Edina, Minnesota 55435, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota 55422-2900, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota 55433, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota 55432, United States

Park Nicollet Cancer Center, St. Louis Park, Minnesota 55416, United States

Ridgeview Medical Center, Waconia, Minnesota 55387, United States

United Hospital, St. Paul, Minnesota 55102, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota 55407, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States

Beth Israel Medical Center - Petrie Division, New York, New York 10003-3803, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

Adena Regional Medical Center, Chillicothe, Ohio 45601, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States

Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States

Fairfield Medical Center, Lancaster, Ohio 43130, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio 43701, United States

Grady Memorial Hospital, Delaware, Ohio 43015, United States

Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio 43055, United States

Mercy Cancer Center at Mercy Medical Center, Canton, Ohio 44708, United States

Mercy Medical Center, Springfield, Ohio 45504, United States

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio 43081, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

St. Rita's Medical Center, Lima, Ohio 45801, United States

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio 45750, United States

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma 74136, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States

Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-0001, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States

Jennersville Regional Hospital, West Grove, Pennsylvania 19390-9499, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

Lewistown Hospital, Lewistown, Pennsylvania 17044, United States

Mount Nittany Medical Center, State College, Pennsylvania 16803, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

York Cancer Center at Apple Hill Medical Center, York, Pennsylvania 17405, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin 54143, United States

Dean Medical Center - Madison, Madison, Wisconsin 53717, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin 54154, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin 54303, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54301-3526, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin 54303, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Featured trial article

Starting date: November 2005
Last updated: June 10, 2008