Comparison of the effectiveness of administration of Centella asiatica extract in comparison with placebo on the prevention of radiation-induced dermatitis in breast cancer patients
Comparison of the frequency of grade 2 and higher of dermatitis in intervention and placebo groups
Comparison of mean severity of dermatitis in intervention and placebo groups
Comparison of the mean onset time of dermatitis in intervention and placebo groups
Comparison of the frequency of radiotherapy discontinuation due to dermatitis in intervention and placebo groups
Comparison of the frequency of dermatitis in intervention and placebo groups
Design
A single center double-blind, randomized, parallel-group clinical trial
Settings and conduct
There is no standard treatment for the prevention and treatment of radiotherapy-induced dermatitis. This clinical trial aim to compare the effectiveness of Centella asiatica extract with placebo in the prevention of radiation-induced dermatitis in breast cancer patients referred to the oncology radiotherapy ward of Namazi Hospital. In this study, participants, clinician, researcher, and outcome assessor will be blind to the study groups.
Participants/Inclusion and exclusion criteria
The study population will include patients with breast cancer if the inclusion criteria such as newly diagnosed disease and the indication for adjuvant radiotherapy includes breast conserving surgery or the presence of a tumor larger than 5 cm or lymph node involvement in the patient underwent modified mastectomy present. Conditions for non-entry of participants including not giving the consent to participate, history of radiation therapy of the breast and chest, history of connective tissue disease and the presence of metastases.
Intervention groups
Patients with breast cancer who are candidates for adjuvant radiotherapy will receive Centella Asiatica extract or placebo from the start of treatment.
Main outcome variables
Frequency of dermatitis grade two and higher; Mean score of severity of dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211231053576N1
Registration date:2022-01-18, 1400/10/28
Registration timing:prospective
Last update:2022-01-18, 1400/10/28
Update count:0
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
Ziba Afshari Aghajari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4332
Email address
ziba.afshar68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of administration of Centella asiatica extract in comparison with placebo on the prevention of radiation-induced dermatitis in breast cancer patients
Public title
Centella asiatica extract on the prevention of radiation-induced dermatitis in breast cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65
The Karnofsky performance scale more and equal 70
Newly diagnosed breast cancer patients
Patients underwent breast conserving surgery
A tumor size more than 5 centimeter in patients underwent mastectomy
Regional lymph-node involvement in patients underwent mastectomy
Conventional radiotherapy regimen
Exclusion criteria:
Not giving consent to participate
Pregnancy
History of breast and chest radiation therapy
History of connective tissue disease such as scleroderma or systemic lupus
Distant metastasis at the presentation
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in the present study is simple randomization using a table of random numbers. Online tools will be used to create a random sequence. Allocation will be made using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, clinician, researcher, and outcome assessor will be blind to the study groups.
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
Zand St., Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology, Secretariat of the Research Ethics Committee
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SUMS.MED.REC.1400.510
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Dermatitis
Timepoint
Weekly during the intervention
Method of measurement
Physical examination
Secondary outcomes
1
Description
Radiotherapy leave
Timepoint
Weekly during the intervention
Method of measurement
History taking
Intervention groups
1
Description
Intervention group: During radiation therapy for breast cancer patients, treatment with Centella Asiatica extract (made by Nature Healing Songs Company, Tehran, Iran) will be done. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting.
Category
Treatment - Drugs
2
Description
Control group: During radiation therapy for breast cancer patients, treatment will be performed with an ointment that is similar in consistency, odor, and color to the intervention group. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting.
Zand St., the central building of Shiraz University of Medical Sciences, the seventh floor
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/Page-ResearchM/fa/205
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
Ziba Afshari Aghajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Namazi Hospital, Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
ziba.afshar68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ziba Afshari Aghajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Namazi Hospital, Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
ziba.afshar68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ziba Afshari Aghajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Namazi Hospital, Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
ziba.afshar68@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Study data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The results of this study can be used for pooled meta-analysis.
From where data/document is obtainable
The data can be accessed by correspondence with the scientific officer. Address: Radiation Oncology ward, Nemazee Teaching Hospital, Namazi Sq., Zand Ave. Shiraz, Fars. 7134814336. Iran Phone +98 71 3647 4332 Cellphone +98 921 165 5956 Fax +98 71 3647 4326 E-mail address mehrdadg239@gmail.com
What processes are involved for a request to access data/document
After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals