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

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sigma-Tau Research, Inc.

Criteria

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