The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Thioctic Acid

Criteria

Inclusion Criteria:

• • Age >18 years.

• Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.

• Measurable disease on CT scan at baseline.

• Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).

• 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:

• ● Diagnosis of Thyroid cancer.

• Presence of other primary cancers.

• Treatment with alpha lipoic acid for any other indication.

• Allergy to alpha lipoic acid.

• Pregnant or lactating women.