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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALC and Placebo
Sponsored by
Sigma-Tau Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALC

Placebo

Arm Description

I g three times daily

1 g three times daily

Outcomes

Primary Outcome Measures

Change of BFI as evaluated from Baseline to Final Visit

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

Full Information

First Posted
November 7, 2007
Last Updated
August 27, 2012
Sponsor
Sigma-Tau Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00555841
Brief Title
Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sigma-Tau Research, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALC
Arm Type
Experimental
Arm Description
I g three times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 g three times daily
Intervention Type
Drug
Intervention Name(s)
ALC and Placebo
Intervention Description
ALC and Placebo
Primary Outcome Measure Information:
Title
Change of BFI as evaluated from Baseline to Final Visit
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Escalante, MD
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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