Name of the Trial
Phase III Randomized Study of Levocarnitine (L-carnitine) for the Management of Fatigue in Cancer Patients (ECOG-4Z02). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E4Z02.

Principal Investigators
Drs. Ricardo Cruciani and Russell Portenoy of the Eastern Cooperative Oncology Group

Why Is This Trial Important?
Fatigue is one of the most common side effects of cancer and cancer treatment. For many people with cancer, fatigue may become a critical issue in their lives, affecting their ability to work, to socialize, to relate to family and friends, and to maintain a healthy lifestyle. Despite its prevalence, however, there is no standard of care for the treatment of fatigue in cancer patients.

Low levels of the nutrient carnitine may contribute to feelings of fatigue in cancer patients. Carnitine plays an important role in cellular energy production by helping in the metabolism of fatty acids, which represent a major fuel source for tissues such as the heart and skeletal muscle. Levocarnitine (L-carnitine) is a nutritional supplement that may help alleviate fatigue by increasing the level of carnitine in the body. In this trial, researchers will assess the prevalence of carnitine deficiencies in cancer patients and examine the effect of carnitine supplementation in patients experiencing moderate to severe fatigue. Patients will be randomly assigned to receive levocarnitine or a placebo.

"Fatigue is a major complaint of many cancer patients, but it is one of the least studied complications of cancer and cancer treatment," said Dr. Cruciani. "With this trial, we hope to learn better how to improve the quality of life and well being of cancer patients."

Who Can Join This Trial?
Researchers seek to enroll 192 patients aged 18 and over who have been diagnosed with any invasive malignant disorder and have experienced moderate to severe fatigue. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/ECOG-E4Z02.

Where Is This Trial Taking Place?
Study sites in the United States are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/ECOG-E4Z02.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E4Z02, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.