Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue

Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue

The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.

The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy

Inclusion Criteria:

• Stage 0-III breast cancer in which adjuvant radiation is indicated;
• Qualifying Brief Fatigue Inventory (BFI) score 6. -

Exclusion Criteria:

• Medication to treat or manage fatigue and pain
• Use of erythropoietin to control anemia
• Clinical evidence of hypothyroidism or hyperthyroidism