Alpha-Lipoic Acid for Mouth Sores Caused by Chemotherapy in Colorectal Cancer
Tests alpha-lipoic acid against mouth sores from 5-fluorouracil in colorectal cancer.
Plain-language title generated from the registry record
Registry title: Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
Key facts
- Where
- Cairo, EgyptSee the site
- Phase
- Phase 2/3
Where in Egypt
- Nasser Institute for Research and Treatment.Cairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT07736495
- Record updated
- 30 July 2026
- Original description
Colorectal cancer (CRC) represents one of the most common cancers worldwide and 5-Fluorouracil (5-FU) is still the mainstay of treatment. However, 5-FU is often implicated in inducing oral mucositis (OM), a painful inflammatory condition that may hinder oral intake, negatively impact quality of life and disrupt adherence with cancer treatment.Read full original descriptionShow less
Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients
Colorectal cancer (CRC) represents one of the most common cancers worldwide and 5-Fluorouracil (5-FU) is still the mainstay of treatment. However, 5-FU is often implicated in inducing oral mucositis (OM), a painful inflammatory condition that may hinder oral intake, negatively impact quality of life and disrupt adherence with cancer treatment.
Oxidative stress and inflammation play a vital role in OM pathogenesis. Alpha-lipoic acid (ALA) is a powerful antioxidant and anti-inflammatory agent that has demonstrated protective effects towards chemotherapy-induced mucosal damage in preclinical studies.
Therefore, ALA may be a promising strategy to minimize or avoid 5-FU-induced oral mucositis in patients with colorectal cancer, which deserves additional clinical investigation.
Inclusion: Age >18 years; Newly diagnosed chemotherapy naive CRC patients; Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy; Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits); Adequate kidney function (estimated glomerular filtration rate >60 ml/min); Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
Exclusion: Treatment with ALA for any other indication; Patients with previous mucositis for any reason; Patients receiving other dietary antioxidant supplements; Presence of other primary cancers; Allergy to ALA; Pregnant or lactating women; Patients who cannot tolerate oral intake.