Prophylactic Oral Vitamin D and Zinc for Radiation-Induced Oral Mucositis in Head and Neck Cancer

NCT06100692 | Unknown

• 1 other identifier: EPUO
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Oncology

Outcome Measures

Primary Outcomes (1)

• oral mucositis scale

  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

  baseline

Study Arms (2)

vit D and zinc group

will receive combination of oral vit D and zinc 30 patients

Drug: Vitamin D

placebo group

receive Placebo or no treatment 30 patients

Interventions

Vitamin D DRUG

the patients will receive a 30 pts a combination of oral vit D and zinc

Also known as: zinc

vit D and zinc group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

maternal and perinatal morbidity and mortality

You may qualify if:

• Selection of patients
• 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 .
• The treatment group will receive combined oral Vit D and Zinc and the control group will take placebo capsules or receive no treatment.
• No documentation of any other causes of oral mucositis in their medical records as : immunocomprmized patients d.t HIV

You may not qualify if:

• Non Head and Neck cancer
• patients with any other causes of oral mucositis
• Double malignancy
• Un eligible patients for radiotherapy ( comatosed, bedridden and sever chest disease )

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Hashim 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 BACKGROUND

• Shuai 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 BACKGROUND

• Rambod 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 BACKGROUND

• Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.

  PMID: 25774860 BACKGROUND

• Anand 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 BACKGROUND

• Sutherland 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 BACKGROUND

• Pulito 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.

  PMID: 33028357 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Vitamin D; Zinc

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Shorooq mostafa, master

CONTACT

01050036903; shorooqmostafa2510@gmail.com

Hoda Hassan, prof

CONTACT

01001732757; Hodahassanessa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at clinical oncology and nuclear medicine

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 25, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11