Determining the effect of rose extract in prevention of radiodermatitis in patients with breast cancer
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients.
Settings and conduct
The study will be conducted in the radiation oncology department of Namazi Hospital affiliated to Shiraz University of Medical Sciences.
Participants in both groups were requested to apply the coded container to the desired area once a day for 5 weeks. This process will be implemented for both the intervention and placebo groups for up to 5 weeks, and every week before the start of radiation therapy, the skin of the radiation treatment area in both the intervention and placebo groups will be examined by the researcher and based on the CTCAE v5.0 checklist for dermatitis.
Participants/Inclusion and exclusion criteria
Entry criteria:
Women over 18 years of age with a histologically confirmed diagnosis of breast cancer who are candidates for radiation therapy after breast surgery
Criteria for not entering the study:
- Inflammatory or metastatic breast cancer
- Severe infection requiring antibiotic treatment
- History of previous radiation therapy for breast cancer
- Lack of consent to participate in the study
Exclusion criteria:
- Failure to use rose oil according to instructions by patients
- Events such as reaction or increased sensitivity to rose oil
- Severe burns in the treated area
Intervention groups
Intervention group: the product containing rosehip extract in olive oil base will be given to patients and they will be requested to apply to the desired area once a day for 5 weeks.
Control group: patients of the placebo group, the product containing olive oil.
Main outcome variables
Dermatitis based on CTCAE grading to evaluate the side effects of radiation therapy on the skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241006063271N1
Registration date:2024-10-09, 1403/07/18
Registration timing:registered_while_recruiting
Last update:2024-10-09, 1403/07/18
Update count:0
Registration date
2024-10-09, 1403/07/18
Registrant information
Name
Mozhdeh Sanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 9094
Email address
sanei_m@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-06, 1403/07/15
Expected recruitment end date
2026-02-04, 1404/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the traditional medicinal product of Rosa damascene in prevention of radiodermatitis in patients with breast cancer
Public title
Investigating the effect of Rosa damascene extract on burns caused by radiation therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer confirmed by histology which are candidates for radiation therapy
Exclusion criteria:
Inflammatory or metastatic breast cancer
Severe infection requiring antibiotic treatment
History of previous radiation therapy for breast cancer
Diabetes
Inflammatory skin disorders
Connective tissue disorders
Simultaneous use of non-steroidal anti-inflammatory drugs
Simultaneous use of corticosteroids and other drugs that suppress the immune system or antioxidants.
The presence of any wounds, scars, burns and any other previous skin damage at the radiation therapy site
Patients with allergy or hypersensitivity to intervention ingredients
Age
From 18 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the two study groups with 1:1 blocks using a random number table (by https://www.random.org).
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug in both the intervention and placebo groups will have the same form and will have a code that another person (other than the people involved in the study) is aware of. Also, the evaluator is not aware of the codes and type of substance available, and based on the code on the drug, they record their evaluation results.
Placebo
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
Street address
Ethics Committee in Research, Research and Technology Deputy, Shiraz University of Medical Sciences Central Building, 7th Floor, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-10-05, 1403/07/14
Ethics committee reference number
IR.SUMS.MED.REC.1403.461
Health conditions studied
1
Description of health condition studied
Dermatitis caused by radiotherapy
ICD-10 code
L58
ICD-10 code description
Radiodermatitis
Primary outcomes
1
Description
Dermatitis based on CTCAE grading to evaluate the side effects of radiation therapy on the skin
Timepoint
Before starting the intervention, the end of each week for 5 weeks
Method of measurement
CTCAE form version 5 to evaluate skin dermatitis caused by radiation therapy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The product containing rose extract based on olive oil (prepared by a pharmacist under the supervision of the Faculty of Pharmacy) will be prepared and will be given in 50 ml jars with a coded label, and they are requested to apply to the desired area once a day for 5 weeks.
Category
Prevention
2
Description
Control group: The patients of the placebo group will receive a product containing olive oil (based on the original product - without rosehip extract), which is packaged in the same containers (in 50 ml jars) as the intervention group, with a coded label, and they will be requested to apply to the desired once a day for 5 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mozhdeh Sanei
Street address
Namazi hospital, Zand st., Namazi sq.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5000
Email
Nemazee_inf@sums.ac.ir
Web page address
https://namazi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research and Technology Deputy, Shiraz University of Medical Sciences Central Building, 7th Floor, Zand Street
City
شیراز
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
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
Mozhdeh Sanei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No. 82, 6th alley, Sattarkhan St.
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3626 9094
Fax
Email
sanei_m@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sanei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No. 82, 6th alley, Sattarkhan St
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3626 9094
Fax
Email
sanei_m@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sanei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No. 82, 6th alley, Sattarkhan St
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3626 9094
Fax
Email
sanei_m@sums.ac.ir
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