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

NCT07736495 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Phase 2/3

Started

2026-07-27

Last updated

2026-07-30

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

alpha lipoic acid 600 mg twice daily →Placebo Tablet

alpha lipoic acid 600 mg twice daily: Thiotex Forte® 600 mg film coated tablets.

Placebo Tablet: Placebo tablets /twice daily for 6 months

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age \>18 years. 2. Newly diagnosed chemotherapy naive CRC patients 3. Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy. 4. Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits). 5. Adequate kidney function (estimated glomerular filtration rate \>60 ml/min). 6. Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3). Exclusion Criteria: 1. Presence of other primary cancers. 2. Treatment with ALA for any other indication. 3. Allergy to ALA. 4. Pregnant or lactating women. 5. Patients with previous mucositis for any reason. 6. Patients who cannot tolerate oral intake. 7. Patients receiving other dietary antioxidant supplements.

Primary outcome measure(s)

Serum levels of malondialdehyde (MDA) — 6 months
serum level of MDA (oxidative stress biomarker) will be assessed at baseline, after 3 months and after 6 months

Trial sites (1)

Facility	City	Region	Status
Nasser Institute for Research and Treatment.	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07736495 on ClinicalTrials.gov ↗ ← All trials in Egypt