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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 ³.

Principal Investigators

Dr. Ricardo Cruciani and Dr. Russell Portenoy of the Eastern Cooperative Oncology Group.

Why This Trial Is 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."

Contact Information

This trial is no longer accepting new patients. To locate other supportive care clinical trials, search the NCI database of clinical trials ¹ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.

Glossary Terms

A substance made in the muscle and liver tissue and found in certain foods, such as meat, poultry, fish, and some dairy products. It is used by many cells in the body to make energy from fatty acids.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the standard of care. Also called best practice and standard therapy.