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

Sponsor
Ain Shams University
Study ID
NCT07736495
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • alpha lipoic acid 600 mg twice daily — DRUG
    Thiotex Forte® 600 mg film coated tablets.
  • Placebo Tablet — OTHER
    Placebo tablets /twice daily for 6 months

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Jul 27, 2026
Status verified
Jul 2026
Primary completion
Dec 27, 2026
Completion
Dec 29, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ALA Group
    ALA Group: patients will receive Alpha lipoic acid 600mg oral tablet twice daily for 6 months
  • Placebo Comparator: Control group
    Control group will receive identical placebo oral tablet twice daily for 6 months

Primary Outcome Measure

Serum levels of malondialdehyde (MDA) [ Time Frame: 6 months ]

Central Contacts

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