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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00555841
• Other study ID #: ST 03-103
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2007
• Last updated: August 27, 2012
• Start date: March 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2012
• Source: Sigma-Tau Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Drug:
• ALC and Placebo
ALC and Placebo

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sigma-Tau Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of BFI as evaluated from Baseline to Final Visit		16 weeks
Secondary	Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12		16 weeks