NCT07736495RecruitingPhase 2/3
Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 Jul 2026
- Start date
- 27 Jul 2026
- Primary completion date
- 27 Dec 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Colorectal cancer
- NCT number
- NCT07736495
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 50
- From 27 Jul 2026 to the primary completion date, 27 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with ALA for any other indication.
- Patients with previous mucositis for any reason.
- Patients receiving other dietary antioxidant supplements.
Other illness
- Presence of other primary cancers.
- Allergy to ALA.
Other
- Pregnant or lactating women.
- Patients who cannot tolerate oral intake.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nasser Institute for Research and Treatment. Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.