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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier:
NCT00555841
First received: November 7, 2007
Last updated: August 27, 2012
Last verified: August 2012
History of Changes

November 7, 2007
August 27, 2012
March 2007
September 2008   (final data collection date for primary outcome measure)
Change of BFI as evaluated from Baseline to Final Visit [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change of BFI as evaluated from Baseline to Final Visit [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00555841 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue
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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
Drug: ALC and Placebo
ALC and Placebo
  • Experimental: ALC
    I g three times daily
    Intervention: Drug: ALC and Placebo
  • Placebo Comparator: Placebo
    1 g three times daily
    Intervention: Drug: ALC and Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555841
ST 03-103
Yes
Sigma-Tau Research, Inc.
Sigma-Tau Research, Inc.
Not Provided
Principal Investigator: Carmen Escalante, MD The University of Texas MD Anderson Cancer Center
Sigma-Tau Research, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP