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Efficacy of vitamin C in prevention of chemoradiation-induced mucositis in the patients with head and neck cancer

Protocol summary

Summary
The aim of present study, is to evaluate the effect of vitamin C using in prevention of mucositis induced by chemoradiation. In a single center randomized double blind clinical trial study with placebo control, 60 patients with head and neck cancer who referred to Shahid-Madani educational-medical center of Tabriz University of Medical Sciences will select randomly and with using random numbers table will allocate in two groups of intervention and control group. Inclusion criteria is, age between 15 to 70 years, and Cisplatin treatment regimen with radiotherapy. Exclusion criteria is any oral active infections, oral ulcers, candidiasis, artificial teeh, corticosteroid use, using tobacco, smoking, alcohol, using opioids, and fever more than 38.5 ° C. Patients in intervention group will receive tab 250 mg of vitamin C daily production of Osvah Pharmaceutical Company, and patients in control group will receive daily a placebo which is similar in shape, color, and flavor to the original drug, for a duration of one month. The severity of mucositis as a primary outcome variable will evaluate by using WHO Toxicity Criteria and patients in both group will evaluate weekly for 4 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112525239N1
Registration date: 2015-12-23, 1394/10/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Farshad Seyyed Nejhad
Name of organization / entity
Department Of Radiotherapy
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 4044
Email address
seyednejadf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Efficacy of vitamin C in prevention of chemoradiation-induced mucositis in the patients with head and neck cancer
Public title
Efficacy of vitamin C in prevention of mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 15 to 70 years; Cisplatin regimen with 45-60 Gy radiation. Exclusion criteria: any oral disease like oral active infections; candidiasis; artificial teeh; using tobacco; smoking; alcohol use; using opioids; and fever more than 38.5 ° C.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will done with Using random numbers table.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Department of Radiotherapy, Shahid Madani Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
TBZMED.REC.1394.731

Health conditions studied

1

Description of health condition studied
Head and neck cancer
ICD-10 code
C00-D48
ICD-10 code description
Neoplasm of uncertain or unknown behaviour of other and unspecified sites

Primary outcomes

1

Description
Severity of mucositis
Timepoint
weekly for 4 weeks
Method of measurement
WHO Toxicity Criteria

Secondary outcomes

empty

Intervention groups

1

Description
In Intervention Group: we will give each day a vitamin C tablet 250mg production of Osvah Pharmaceutical Company for a month.
Category
Prevention

2

Description
In Control Group: we will give a placebo of Vitamin C tablet 250 mg production of Osvah Pharmaceutical Company each day for a month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Dr Farshad Seyyed Nejhad
Street address
Department of Radiotherapy, Shahid Madani Hospital, Daneshgah Street, Tabriz.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University Of Medical Sciences.
Full name of responsible person
Dr Farshad Seyyed Nejhad
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Solmaz Sadeghi
Position
Doctor of Medicine (MD)
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
afsaneh7927sgh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department Of Radiotherapy, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Farshad Seyyed Nejhad
Position
Oncology and radiotherapy Specialist.
Other areas of specialty/work
Street address
Department of Radiotherapy, Shahid Madani Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3337 3919
Fax
Email
fnejad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Solmaz Sadeghi
Position
Doctor of Medicine (MD)
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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