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RECRUITING
NCT07736495
PHASE2/PHASE3

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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

Interventions

DRUG

alpha lipoic acid 600 mg twice daily

Thiotex Forte® 600 mg film coated tablets.

OTHER

Placebo Tablet

Placebo tablets /twice daily for 6 months

Locations (1)

Nasser Institute for Research and Treatment.

Cairo, Egypt