Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis | NCT07736495

NCT07736495

Overview

NCT ID: NCT07736495
Lead Sponsor: Ain Shams UniversityOTHER
Official Title: Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients
Brief 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age >18 years.

Newly diagnosed chemotherapy naive CRC patients

Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy.

Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).

Adequate kidney function (estimated glomerular filtration rate >60 ml/min).

Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).

Exclusion Criteria:

Presence of other primary cancers.

Treatment with ALA for any other indication.

Allergy to ALA.

Pregnant or lactating women.

Patients with previous mucositis for any reason.

Patients who cannot tolerate oral intake.

Patients receiving other dietary antioxidant supplements.

Central Contacts: Ghada Ramadan YoussefContact
ghada.ms2425015@pharma.asu.edu.eg+20 01097001838