effect of dermolin henna cream on radiotherapy dermatitis compare to strata XRT
Design
We examine the cases each week in radiotherapy and after dermatitis grade 2, we give them the creams to use 2 timed a day after treatment.
Settings and conduct
In each group, after grade 2 dermatitis, they should use cream. Imam Hossein Hospital. Radiation oncology department
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Breast cancer
women 18-70 years
radiotherapy to breast
Caes who have breast conservative surgery not mastectomy
Exclusion criteria:
ulcer or unhealed scar or cellulitis in the field of radiotherapy
history of diabetes - renal failure- anemia- hypertension
history of collagen vascular disease
deformity of chest wall
history of chronic skin disease on chest wall
breast concurrent chemoradiation
history of radiotherapy to breast or chest
Intervention groups
There are two groups. There is no control group. This is a pilot study and due to limited number of Strata XRT cream (20), we can have only 20 cases in each group.
Main outcome variables
Age
Dermatitis grade (due to RTOG grading system)
Total dose of radiotherapy
Dose of radiotherapy when grade 2 dermatitis appears
Drug adverse effects
pain
Itching
Burning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024084N2
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Shaghayegh Kamian
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 311 4846
Email address
shkamian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of dermoline- henna cream with Strata XRT cream onradiodermatitis in breast cancer
Public title
Comparison of the efficacy of dermoline- henna cream with Strata XRT cream on radiodermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Breast cancer
women 18-70 years
radiotherapy to breast
Breast conservative surgery
Exclusion criteria:
ulcer or unhealed scar or cellulitis in
history of diabetes - renal failure- anemia- hypertension
history of collagen vascular disease
deformity of chest wall
history of chronic skin disease on chest wall and breast
concurrent chemoradiation
history of radiotherapy to breast or chest
Age
From 18 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a pilot study with 20 cases in each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
from day 1 of radiotherapy till the end of it, weekly
Method of measurement
(Radiation Oncology Grading Group) RTOG grading system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: There are 20 cases in this group. We give the patients the cream that its base is dermolin henna when there is dermatitis grade 2 in the the field of radiotherapy.
Category
Treatment - Drugs
2
Description
Intervention group 2: There are 20 cases in the second group. We give the patients Starat XRT cream when there is dermatitis grade 2 in the the field of radiotherapy.