Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Presence of other primary cancers.
Treatment with ALA for any other indication.
Allergy to ALA.
Pregnant or lactating women.
Trial design
Treatments tested in this trial
- alpha lipoic acid 600 mg twice daily
- Placebo Tablet
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov