The effect of vitamin D supplementation on the treatment of head and neck cancer patients

Phase 3

Recruiting

• Conditions: Head and Neck Squamous-Cell Carcinoma.; Malignant neoplasm of connective and soft tissue of head, face and neck; C49.0

• Registration Number: IRCT20230926059515N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Patients with histopathologically proven head and neck squamous cell carcinoma
Age 20 to 75 years

Exclusion Criteria

Previous use of vitamin D supplements
History of previous chemoradiotherapy
Allergy to vitamin D supplements
The presence of metastasis
Failure to complete the standard treatment protocol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor recurrence through clinical examination and imaging: Tumor recurrence in the primary site of the tumor underwent surgery, tumor recurrence in a place other than the primary tumor site, such as the involvement of other organs than the head and neck. Timepoint: 1.5 years. Method of measurement: Clinical examination or imaging if necessary.

Secondary Outcome Measures

Name	Time	Method
Response to chemoradiotherapy by clinical examination and imaging: tumor volume reduced by less than 50% of the initial amount: no response, tumor volume reduced by more than 50% of the initial amount: partial response, no residual tumor: complete answer. Timepoint: 1.5 year. Method of measurement: Clinical examination or imaging if necessary.