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Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
Sponsor: Ain Shams University
Summary
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.
Official title: Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-27
Completion Date
2026-12-29
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
alpha lipoic acid 600 mg twice daily
Thiotex Forte® 600 mg film coated tablets.
Placebo Tablet
Placebo tablets /twice daily for 6 months
Locations (1)
Nasser Institute for Research and Treatment.
Cairo, Egypt