Introducing a new and effective drug to radiation oncologists in order to prevent radiation-induced skin inflammation in patients with breast cancer
Design
Clinical trial with control group, parallel groups, 100 patients, without blindness, randomized according to random numbers obtained from www.random.org.
Settings and conduct
The patients referring to the radiation oncology department of Namazi hospital in Shiraz are divided into 2 groups of 50 people. The intervention group, from the first day of radiotherapy, wash twice a day, 6 hours apart, with the water and soap first, and then the StrataXRT gel are applied to the wall of the chest with a thickness of 1-2 mm.The control group only wash the area with water and soap.Both groups are examined on a weekly basis and in the event of grade II dermatitis, they are treated as usual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with newly diagnosed breast cancer undergoing radical mastectomy and candidate for radiation therapy, no contraindication for radiotherapy, three weeks after chemotherapy, not receiving simultaneously chemotherapy and Herceptin.
Exclusion criteria: All patients with history of radiation therapy of breast, Patients with a history of systemic or cutaneous diseases.
Intervention groups
Patients are divided into intervention and control groups.The intervention group uses the StrataXRT gel twice daily on the chest wall radiotherapy day after the first day of radiation therapy. The control group will have just daily rinses radiation treatment. Both groups are examined weekly.
Main outcome variables
Grading of dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041507N1
Registration date:2018-12-31, 1397/10/10
Registration timing:registered_while_recruiting
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Zahra Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4352 3347
Email address
z.e01365@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigation of Prophylactic Effect of StrataXRT Gel on Radiation Therapy Induced Dermatitis in Breast Cancer Patients.
Public title
Prophylactic Effect of StrataXRT Gel on Radiation Therapy Induced Dermatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with newly diagnosed breast cancer undergoing radical mastectomy and candidate for radiation therapy.
Signing the informed consent form.
No contraindication for radiotherapy.
Three weeks after chemotherapy.
Not receiving simultaneously chemotherapy and Herceptin.
Exclusion criteria:
All patients with history of radiation therapy of breast.
A history of systemic or cutaneous diseases such as diabetes mellitus or collagen vascular disease, and concomitant use of wound healing drugs such as systemic steroids.
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Among patients referring to the radiation oncology department of Namazi hospital in Shiraz, who have breast cancer and undergo radical mastectomy and candidate for radiotherapy, will be randomly underwent radiation therapy, and 100 patients will be randomly placed in two main groups (StrataXRT) or control group according to randomized numbers obtaining from the website : www.random.org
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Intervention group: One group of patients from the first day will use the StrataXRT gel twice daily and 5 consecutive days per week for 5-5.5 weeks on radiotherapy area, which has already been identified by the treatment planning system. Patients should wash the radiation site twice daily with water and soap, and then used StrataXRT gel on chest wall with 1-2 mm thickness, and before radiation therapy, to prevent further burns, rinse the area with water and soap. The time interval between using Strata XRT gel twice per day is six hours. this group are examined weekly and in case of second grade dermatitis, they are treated in both groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following table. This drug contains compounds: polidimetilsilossani,silossani,alchilmetil siliconi, and the compani is manufacturing stratpharma switzerland.
Category
Prevention
2
Description
Control group: This group is considered as a control and it is also recommended that they daily wash the radiotherapy area, such as the intervention group and examined weekly and in case of second grade dermatitis, they are treated in the groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following special table.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Zahra Eskandari
Street address
Radiation Therapy Department., Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
Z_Eskandari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice Chancellor for Research,. Shiraz University of Medical Sciences., Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3212 2430
Email
Vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Eskandari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No. 216, Alawi student dormitory., 2Alley.، Mollasadra St.
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 4352 3347
Fax
Email
Z.e01365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Omidvari Shapoor
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Hospital Namazi., Zand Street.
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Email
Omidvari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mohammadian Panah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Hospital Namazi., Zand Street.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4320
Email
mohpanah@gmail.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