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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change of BFI as evaluated from Baseline to Final Visit

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Carmen Escalante, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ST 03-103

NCT ID:

NCT00555841

Start Date:

March 2007

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009