Investigating the Clinical Effects of Boron Based Gel on the Prevention or Restoring of Radiotherapy Dermatitis in Neck, Head and Breast Cancer Patients
Investigating the Clinical Effects of Boron-based Gel on the Remediation and Prevention of Dermatitis and Radiation Traumatic Causes
Design
Intervention group: During each radiation therapy session, 15 minutes before radiotherapy, 3% sodium pentahydrate panteurate will be used. Control group: During each radiotherapy session, 15 minutes before radiotherapy, the gel will be free of any chemical treatments. With 95% confidence, test power of 95% and using G-Power software, the minimum sample size of 89 items in each group was calculated and with a 10% drop, the sample size was increased to 100 cases per group. Clinical randomized and double blind clinical trials will be conducted.
Settings and conduct
100 patients in the head and neck area and 100 patients undergoing radiation therapy should be enrolled in this study. The first group will use 3% sodium pentahydrate sodium in the radiotherapy area before each radiation therapy. And the second group will receive a placebo. Patients will be examined within 25 days of radiotherapy treatment with radiation-induced dermatitis. This research will be carried out in the radiotherapy department of the Martyr Madani Hospital in Tabriz.
Participants/Inclusion and exclusion criteria
Entry: Patients who are admitted to the study are enrolled in the study and have head and neck cancer in the breast, and are between the ages of 18 and 75 years old and have not received radiotherapy before.
Exit: Patients with cancer other than head and neck and breast. Patients aged less than 18 and over 75 years old. Pregnant patients.
Intervention groups
During each radiation therapy session, 15 minutes before radiotherapy, 3% sodium glycosolium pentahydrate will be used.
Main outcome variables
Radiation-induced skin reactions; Group radiation therapy oncology
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042925N1
Registration date:2019-04-29, 1398/02/09
Registration timing:registered_while_recruiting
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Farshad Seyed Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 6436
Email address
fnejad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-05, 1397/11/16
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Clinical Effects of Boron Based Gel on the Prevention or Restoring of Radiotherapy Dermatitis in Neck, Head and Breast Cancer Patients
Public title
Investigating the Clinical Effects of Boron-based Gel on Restorative Dermatoses and Radiation Traumatic Causes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who agree to enroll in the study
Patients with head and neck and breast cancer who decide to use radiotherapy to spend time on chemotherapy.
Patients older than 18 years of age and below 75 years
Patients who have not received radiotherapy before
Exclusion criteria:
Patients with cancer other than head and neck and breast
Pregnant patients
Patients with dermatitis regardless of cause
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Given the fact that the sample size is the same in both groups, we use the Excel software and the formula = Rand () to randomize and to increase the precision and balance of the samples in the randomization (for any reason Patient will withdraw from the plan) We use several blocks per group. It will also be provided to the physician to cover the allocation of matte envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
A gel that has an active ingredient in boron with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz, Azadi St., Golghast St., Central building of Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.TBZMED.REC.1397.919
Health conditions studied
1
Description of health condition studied
Radiotherapy-induced dermatitis in patients with neck and head and breast cancers
ICD-10 code
L59.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue related to radiation
Primary outcomes
1
Description
RISR
Timepoint
25 days
Method of measurement
FPHS
2
Description
RTOG
Timepoint
25 days
Method of measurement
FPHS
Secondary outcomes
empty
Intervention groups
1
Description
Control group: During each radiotherapy session, 15 minutes before radiotherapy, the gel will be free of any chemical treatments.
Category
Placebo
2
Description
Intervention group: uring each radiation therapy session, 15 minutes before radiotherapy, 3% sodium will be used for pentahydrate panteoborate.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical & Training Hospital - Department of Radiotherapy
Full name of responsible person
Farshad Seyednejad
Street address
Tabriz - University Street - Facing the Golbad
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
fnejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farshad Seyed Nejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
East Azerbaijan Province, Tabriz, Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
fnejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farshad Seyed Nejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
fnejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farshad Seyed Nejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
fnejad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data will be shared
When the data will become available and for how long
2020
To whom data/document is available
University researchers and professors
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
via email
What processes are involved for a request to access data/document