RecruitingPhase 2Phase 3NCT07736495

Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis

Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients


Sponsor

Ain Shams University

Enrollment

50 participants

Start Date

Jul 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo Tablet and a drug called alpha lipoic acid 600 mg twice daily for people with colorectal, cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGalpha lipoic acid 600 mg twice daily

Thiotex Forte® 600 mg film coated tablets.

OTHERPlacebo Tablet

Placebo tablets /twice daily for 6 months


Locations(1)

Nasser Institute for Research and Treatment.

Cairo, Egypt

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NCT07736495


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