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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: ALC and Placebo
Phase 2

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sigma-Tau Research, Inc.:

Primary Outcome Measures:
  • Change of BFI as evaluated from Baseline to Final Visit [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALC
I g three times daily
Drug: ALC and Placebo
ALC and Placebo
Placebo Comparator: Placebo
1 g three times daily
Drug: ALC and Placebo
ALC and Placebo

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555841

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sigma-Tau Research, Inc.
Investigators
Principal Investigator: Carmen Escalante, MD The University of Texas MD Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier: NCT00555841     History of Changes
Other Study ID Numbers: ST 03-103
Study First Received: November 7, 2007
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sigma-Tau Research, Inc.:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014