Evaluation of vitamin D supplementation on treatment results of patients with head and neck Squamous-Cell Carcinoma
Design
The clinical trial study has a controlled group, parallel-group, triple-blind, randomized, phase 3 clinical trial on 110 patients. Coin the Flip method was used for randomization.
Settings and conduct
This study will be conducted from May 2022 to November 2023 at Shafa Hospital in Kerman on all patients with squamous cell cancer. Patients are divided into two intervention and control groups by random allocation and using the coin toss method. Vitamin D is given to the intervention group and a placebo to the control group for 3 months. Then the patients are subjected to surgery, chemotherapy, radiotherapy, or a combination of these treatments and the rate of survival, recurrence, or response to the treatment is checked within a period of 1.5 years.
Patients, researcher, and analysts are blind to the type of treatment.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: 1- Histopathological proven head and neck squamous cell cancer and age 20 to 75 years. Exclusion criteria include: 1- previous use of vitamin D supplements 2- history of previous chemoradiotherapy 3- sensitivity to vitamin D supplements 4- the presence of metastasis 5- failure to complete the standard treatment protocol.
Intervention groups
The intervention group will be given vitamin D supplements at a dose of 2000 units per day and the control group will be given a placebo for three months.
Main outcome variables
Survival rate, recurrence, or response to treatment
General information
Reason for update
Acronym
Squamous-Cell Carcinoma (SCC)
IRCT registration information
IRCT registration number:IRCT20230926059515N1
Registration date:2023-10-07, 1402/07/15
Registration timing:registered_while_recruiting
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Mohammad Ali Damghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 5780
Email address
ma_damghani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D supplementation on the treatment of patients with head and neck Squamous-Cell Carcinoma (SCC)
Public title
The effect of vitamin D supplementation on the treatment of head and neck cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway,
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-04-28, 1401/02/08
Ethics committee reference number
IR.KMU.AH.REC.1401.021
Health conditions studied
1
Description of health condition studied
Head and Neck Squamous-Cell Carcinoma
ICD-10 code
C49.0
ICD-10 code description
Malignant neoplasm of connective and soft tissue of head, face and neck
Primary outcomes
1
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital, Kerman
Full name of responsible person
Mohammad Ali Damghani
Street address
Shafa Hospital, Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
ma_damghani@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Ali Damghani
Street address
Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
ma_damghani@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Niloofar Mohammadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
nmohammadi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Ali Damghani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
ma_damghani@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Niloofar mohammadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
nmohammadi13@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the publication of the results in the form of an article, there is no need to publish the details of the data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information related to the main outcome of the study will be shared
When the data will become available and for how long
The access period starts 6 months after publishing the results
To whom data/document is available
Researchers to reanalyze the data
Under which criteria data/document could be used
Reviewers of scientific journals before publishing the article
From where data/document is obtainable
Corresponding author
Mohammad Ali Damghani
ma_damghani@kmu.ac.ir
Student - Nilofar Mohammadi
nmohammadi13@yahoo.com
What processes are involved for a request to access data/document
Request with sufficient reasons by email
Review and consultation of the research team
The decision for data presentation