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IRCT20230926059515N1 IRCT 2023-10-07 Kerman University of Medical Sciences The effect of vitamin D supplementation on the treatment of head and neck cancer patients Squamous-Cell Carcinoma (SCC) Evaluation of vitamin D supplementation on the treatment of patients with head and neck Squamous-Cell Carcinoma (SCC) 2022-05-22 anticipated 110 Complete https://irct.ir/trial/72776 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into intervention and control groups using simple random allocation. Coin the Flip method was used for randomization. This method is usually used to create a random sequence in two-group experiments. In this study, the milk intervention group and the line control group were considered. Based on the desired sample size, a coin is tossed and people are divided into two groups by random allocation, Blinding description: The patients are unaware of the medicine they are receiving, and the control group is given a placebo. The complete response rate and the partial response rate to the treatment are checked by the researcher who does not know the type of treatment received by the patients. The coded variables are compared between the intervention and control groups by an analyst who does not know the type of treatment. 3 Head and Neck Squamous-Cell Carcinoma. The intervention group was supplemented with vitamin D (manufactured by Ariafarmed Peshgaman Salamat Pharmaceutical Company) at a dose of 2000 units per day and the control group (second) received placebo for three months.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the publication of the results in the form of an article, there is no need to publish the details of the data
public Niloofar Mohammadi
Shafa Hospital, Kosar Blvd, Kerman
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5780 nmohammadi13@yahoo.com Kerman University of Medical Sciences scientific Mohammad Ali Damghani
Shafa Hospital, Kosar Blvd, Kerman
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5780 ma_damghani@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with histopathologically proven head and neck squamous cell carcinoma Age 20 to 75 years 20 years 75 years Both 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 C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck Treatment - Drugs The intervention group was supplemented with vitamin D (manufactured by Ariafarmed Peshgaman Salamat Pharmaceutical Company) at a dose of 2000 units per day and the control group (second) received placebo for three months. 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. 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. Kerman University of Medical Sciences Approved 2022-04-28 Research Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman Kerman Iran (Islamic Republic of)