Clinical trial · Interventional
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
NCT05023863CI-TRIAL-00053564unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha Lipoic Acid 600 MG Oral Tablets | Drug | — | UNRESOLVED |
| Placebo tablets | Other | — | UNRESOLVED |
| radiation or concurrent chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Alpha Lipoic Acid Group (intervention group)
- description
- 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). .
- interventionNames
- Drug: Alpha Lipoic Acid 600 MG Oral Tablets
- Radiation: radiation or concurrent chemoradiation
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- 35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period)
- interventionNames
- Other: Placebo tablets
- Radiation: radiation or concurrent chemoradiation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (20)
- BACKGROUNDAl Abdan M. Alfa-lipoic acid controls tumor growth and modulates hepatic redox state in Ehrlich-ascites-carcinoma-bearing mice. ScientificWorldJournal. 2012;2012:509838. doi: 10.1100/2012/509838. Epub 2012 May 1. PMID 23002387
- BACKGROUNDBloomer WD, Hellman S. Normal tissue responses to radiation therapy. N Engl J Med. 1975 Jul 10;293(2):80-3. doi: 10.1056/NEJM197507102930206. No abstract available. PMID 1093032
- BACKGROUNDEisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. PMID 19097774
- BACKGROUNDElsabagh HH, Moussa E, Mahmoud SA, Elsaka RO, Abdelrahman H. Efficacy of Melatonin in prevention of radiation-induced oral mucositis: A randomized clinical trial. Oral Dis. 2020 Apr;26(3):566-572. doi: 10.1111/odi.13265. Epub 2020 Jan 15. PMID 31869853
- BACKGROUNDGillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002. PMID 18809146
- BACKGROUNDJung JH, Jung J, Kim SK, Woo SH, Kang KM, Jeong BK, Jung MH, Kim JH, Hahm JR. Alpha lipoic acid attenuates radiation-induced thyroid injury in rats. PLoS One. 2014 Nov 17;9(11):e112253. doi: 10.1371/journal.pone.0112253. eCollection 2014. PMID 25401725
- BACKGROUNDKim H, Yoo WS, Jung JH, Jeong BK, Woo SH, Kim JH, Kim SJ. Alpha-Lipoic Acid Ameliorates Radiation-Induced Lacrimal Gland Injury through NFAT5-Dependent Signaling. Int J Mol Sci. 2019 Nov 13;20(22):5691. doi: 10.3390/ijms20225691.