Evaluation of the effectivness of hydrogel containing Purslane extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients
ِDtermination of the effectivness of hydrogel containing Portulaca oleracea extract on the management of radiotherapy-induced mucositis
Design
A double-blind, randomized, placebo-controlled, Phase 2-3 clinical trial study will be performed on 80 individuals divided into two groups.
Settings and conduct
The study will be performed in patients referred to the clinics of Babol and Mashhad University of Medical Sciences. Patients are randomly assigned medication and placebo after obtaining informed consent. Patients will use the hydrogel twice a day based on the fingertip unit for six weeks and will be evaluated weekly by an oncologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with diagnosed breast cancer, age 18 years and older, no skin tumour tissue, no concomitant chemotherapy, no previous chest radiotherapy, minimum 50 Gy radiation during treatment, BMI 20-30, Breast-conserving surgery
Exclusion criteria: patients with underlying diseases, hypersensitivity to Portulaca oleracea, patients with metastatic carcinoma to the breast, Inability of the patient to implement the treatment protocol
Intervention groups
Placebo group: Placebo hydrogel containing glycerin and green dye made by Mashhad University of Medical Sciences, Intervention group: hydrogel containing 2% Portulaca oleracea extract and glycerin content made by Mashhad University of Medical Sciences
Main outcome variables
Incidence and severity of chemotherapy-induced mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N8
Registration date:2021-07-27, 1400/05/05
Registration timing:registered_while_recruiting
Last update:2021-07-27, 1400/05/05
Update count:0
Registration date
2021-07-27, 1400/05/05
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectivness of hydrogel containing Purslane extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients
Public title
The effect of Portulaca oleracea hydrogel on the prevention of radiotherapy-induced dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients diagnosed with breast tissue cancer
Age over 18 years
No concomitant chemotherapy
No previous radiotherapy to the chest area
Minimum radiation of 50 Gy during treatment
BMI 20-30
Breast conserving surgery
Exclusion criteria:
Existence of underlying diseases
hypersensitivity to Portulaca oleracea
Patients with metastatic carcinoma to the breast
Inability of the patient to implement the treatment protocol
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method, the size of blocks is equal to four with two members A and B in a ratio of 1: 1. Based on the sample size, 20 blocks are numbered in a different order from 1 to 20 and a random sequence of 20 blocks is determined using the site "www.Randomaize.com", then the sequence of treatment groups A and B is determined in envelopes with number 1 Up to 80, with the inclusion of each eligible person, the envelope corresponding to the person's number is opened and the treatment group is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the use of a placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.MUMS.REC.1400.070
Health conditions studied
1
Description of health condition studied
Radiotherapy-induced mucositis is breast-conserving cancer patients
ICD-10 code
L58.0, L27
ICD-10 code description
Acute radiodermatitis, Localized skin eruption due to drugs and medicament
Primary outcomes
1
Description
Incidence of dermatitis
Timepoint
At the beginning of the study and every week for 6 weeks
Method of measurement
Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG)
2
Description
Severity of dermatitis
Timepoint
At the beginning of the study and every week for 6 weeks
Method of measurement
Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG)
Secondary outcomes
1
Description
Quality of life
Timepoint
at the beginning and the end of the study
Method of measurement
Ware & Sherbourne's quality of life questionnaire
Intervention groups
1
Description
Control group: Patients undergo radiotherapy, will receive placebo hydrogel containing glycerin and green dye made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks.
Category
Placebo
2
Description
Intervention group: Patients undergo radiotherapy, will receive hydrogel containing 2% Portulaca oleracea extract and glycerin content made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
2
Recruitment center
Name of recruitment center
Clinics affiliated to Babol University of Medical Sciences
Full name of responsible person
Dr Danial Fazilatpanah
Street address
Babol University of Medical Science, Ganj Afrouz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
drfazilatpanah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available