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

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ClinicalTrials.gov Identifier: NCT00555841
Recruitment Status : Terminated (Sponsor decision)
First Posted : November 9, 2007
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Sigma-Tau Research, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: ALC and Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change of BFI as evaluated from Baseline to Final Visit [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier: NCT00555841     History of Changes
Other Study ID Numbers: ST 03-103
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms