Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue
Phase 2
Terminated
- Conditions
- Breast Cancer
- Interventions
- Drug: ALC and Placebo
- Registration Number
- NCT00555841
- Lead Sponsor
- Sigma-Tau Research, Inc.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALC ALC and Placebo I g three times daily Placebo ALC and Placebo 1 g three times daily
- Primary Outcome Measures
Name Time Method Change of BFI as evaluated from Baseline to Final Visit 16 weeks
- Secondary Outcome Measures
Name Time Method Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12 16 weeks
Trial Locations
- Locations (1)
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States