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

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.

Full Title of Study: “Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2008

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

Interventions

  • Drug: ALC and Placebo
    • ALC and Placebo

Arms, Groups and Cohorts

  • Experimental: ALC
    • I g three times daily
  • Placebo Comparator: Placebo
    • 1 g three times daily

Clinical Trial Outcome Measures

Primary Measures

  • Change of BFI as evaluated from Baseline to Final Visit
    • Time Frame: 16 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sigma-Tau Research, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carmen Escalante, MD, Principal Investigator, The University of Texas MD Anderson Cancer Center

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