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

Phase 2TerminatedNCT00555841

Sigma-Tau Research, Inc.27 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Breast Cancer

Interventions

ALC and PlaceboDRUG

ALC and Placebo

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Change of BFI as evaluated from Baseline to Final Visit

Time frame: 16 weeks

Secondary Outcomes

Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12

Time frame: 16 weeks

Data from ClinicalTrials.gov

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