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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change of BFI as evaluated from Baseline to Final Visit
16 weeks
No
Carmen Escalante, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
United States: Food and Drug Administration
ST 03-103
NCT00555841
March 2007
September 2008
Name | Location |
---|---|
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |