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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00555841

Run by

Sigma-Tau Research, Inc.

People needed

27

Starts

2007-03-01

Expected to finish

2008-09-01

Last updated by the study team

2012-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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