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

Sigma-Tau Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: ALC and Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555841

ST 03-103

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

ALC

Experimental group

Description:

I g three times daily

Treatment:

Drug: ALC and Placebo

Placebo

Placebo Comparator group

Description:

1 g three times daily

Treatment:

Drug: ALC and Placebo