Clinical trial · Interventional
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
NCT00555841CI-TRIAL-00007899terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALC and Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALC
- description
- I g three times daily
- interventionNames
- Drug: ALC and Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1 g three times daily
- interventionNames
- Drug: ALC and Placebo
Primary outcomes (1)
- measure
- Change of BFI as evaluated from Baseline to Final Visit
- timeFrame
- 16 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.