Clinical trial · Observational
Prophylactic Oral Vitamin D and Zinc for Radiation-Induced Oral Mucositis in Head and Neck Cancer
Effect of Prophylactic Use of Oral Vitamin D and Zinc in Management of the Severity of Radiation Induced Oral Mucositis of Head and Neck Cancer Patients
NCT06100692CI-TRIAL-00071096unknownClinicalTrials.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)
The main aim of this study was to evaluate clinically the effect of a combination between oral vitamin D and oral zinc in comparison to conventional therapy in prevention of radiotherapy-induced oral mucositis in Assiut University Hospitals.
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 |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- vit D and zinc group
- description
- will receive combination of oral vit D and zinc 30 patients
- interventionNames
- Drug: Vitamin D
- label
- placebo group
- description
- receive Placebo or no treatment 30 patients
Primary outcomes (1)
- measure
- oral mucositis scale
- timeFrame
- baseline
- description
- The Oral Mucositis Assessment Scale (OMAS) is an objective scale that measures erythema and ulceration at nine sites within the oral cavity grade0:(none) grade1(mild): oral soreness and erythema grade 2(moderate):oral erythema ,ulcers, solid diet tolerance grade 3(sever) :liquids diet only grade 4(life threatening) oral alimentation impossible
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Selection of patients 1. All adults (18 years or older ), who were confirmed based on pathology ( Head and Neck Squamous Cell Carcinomas ), will administere chemo-radiotherapy either as preoperative (neoadjuvant), postoperative (adjuvant) therapy or definitive therapy, no randomization . 2. The treatment group will receive combined oral Vit D and Zinc and the control group will take placebo capsules or receive no treatment. 3. No documentation of any other causes of oral mucositis in their medical records as : immunocomprmized patients d.t HIV Exclusion Criteria: 1. Non Head and Neck cancer 2. patients with any other causes of oral mucositis 3. Double malignancy 4. Un eligible patients for radiotherapy ( comatosed, bedridden and sever chest disease )
References
Publications (7)
- BACKGROUNDHashim D, Sartori S, La Vecchia C, Serraino D, Maso LD, Negri E, Smith E, Levi F, Boccia S, Cadoni G, Luu HN, Lee YA, Hashibe M, Boffetta P. Hormone factors play a favorable role in female head and neck cancer risk. Cancer Med. 2017 Aug;6(8):1998-2007. doi: 10.1002/cam4.1136. Epub 2017 Jul 14. PMID 28707400
- BACKGROUNDShuai T, Yi LJ, Tian X, Chen WQ, Chen H, Li XE. Prophylaxis with oral zinc sulfate against radiation-induced oropharyngeal mucositis in patients with head and neck cancer: Protocol for a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13310. doi: 10.1097/MD.0000000000013310. PMID 30508920
- BACKGROUNDRambod M, Pasyar N, Ramzi M. The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. Eur J Oncol Nurs. 2018 Apr;33:14-21. doi: 10.1016/j.ejon.2018.01.007. Epub 2018 Feb 2. PMID 29551172
- BACKGROUNDVilla A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180. PMID 25774860
- BACKGROUNDAnand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30. PMID 28947884
- BACKGROUNDSutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5. PMID 11240232
- BACKGROUNDPulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.