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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555841

Enrollment

Registered

2007-11-09

Start date

2007-03-31

Completion date

2008-09-30

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer

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

Interventions

DRUGALC and Placebo

ALC and Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change of BFI as evaluated from Baseline to Final Visit	16 weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026