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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014