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

NCT07736495 | Recruiting Phase 2

• 1 other identifier: 454
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Colorectal Cancer

Keywords

Alpha lipoic acid; Colorectal cancer; Oral Mucositis; 5-Fluorouracil; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• Serum levels of malondialdehyde (MDA)

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

  6 months

Secondary Outcomes (8)

• Incidence of 5FU-induced oral mucositis

  6 months

• Time to develop grade 2 or more Oral Mucositis

  6 months

• Duration of grade 3 or 4 Oral Mucositis

  6 months

• Number of participants with dose delay/ reduction in chemotherapy due to Oral Mucositis development.

  6 months

• Assessment of pain score.

  6 months

Study Arms (2)

ALA Group

EXPERIMENTAL

ALA Group: patients will receive Alpha lipoic acid 600mg oral tablet twice daily for 6 months

Drug: alpha lipoic acid 600 mg twice daily

Control group

PLACEBO COMPARATOR

Control group will receive identical placebo oral tablet twice daily for 6 months

Other: Placebo Tablet

Interventions

alpha lipoic acid 600 mg twice daily DRUG

Thiotex Forte® 600 mg film coated tablets.

ALA Group

Placebo Tablet OTHER

Placebo tablets /twice daily for 6 months

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Nasser Institute for Research and Treatment.

Cairo, Egypt

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Colorectal Neoplasms; Stomatitis; Inflammation

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Central Study Contacts

Ghada Ramadan Youssef

CONTACT

+20 01097001838; ghada.ms2425015@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each patient in the Control group will receive a placebo tablet which is identical in appearance, size, and color to the active treatment tablet, administered for the same duration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)