Evaluation of effectiveness and safety of montelukast gel in prevention of acute radiation dermatitis in breast cancer patients
Design
This study is a double-blind, randomized, placebo-controlled clinical trial.
Settings and conduct
This study will be performed in the radiotherapy department of Vali'asr Hospital affiliated with ZUMS (Zanjan, Iran). The eligible participants were randomly allocated to receive the montelukast gel or placebo. All applications of the gel will be started on day 1 of radiotherapy and continued during and for 4 weeks after the completion of the radiation. The patients will be advised to apply a thin layer of their allocated gel of the area of skin being irradiated, twice a day at least two hours before and after radiotherapy and during radiotherapy, patients were approached to adhere to skincare recommendations of clinical practice guidelines for the prevention of acute radiation reactions from the MASCC Skin toxicity study group. The patients, researchers, and the radio-oncologists were not aware of the patients' allocated group.
Participants/Inclusion and exclusion criteria
Female patients (age ≥18 years) with histologically confirmed localized invasive breast carcinoma who were scheduled to receive at least 50 Grays of adjuvant radiotherapy after breast surgery are included in this study. Patients with a prior history of chest radiotherapy, concurrent chemotherapy (except trastuzumab and hormonal therapy), inflammatory or metastatic breast carcinoma, generalized skin disorders, connective tissue disorders, known hypersensitivity to montelukast, or any other excipients of gel are excluded from the study.
Intervention groups
Montelukast gel
Placebo gel
Main outcome variables
The primary endpoint is to determine whether the montelukast gel can reduce the incidence of acute radiation dermatitis in comparison to placebo using RTOG/EROTC criteria.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211029052907N2
Registration date:2022-02-14, 1400/11/25
Registration timing:prospective
Last update:2022-02-14, 1400/11/25
Update count:0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Monireh Maham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
m.maham@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness and safety of montelukast gel in prevention of acute radiation dermatitis in breast cancer patients .
Public title
Evaluation of montelukast gel effect on prevention of radiation acute dermatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
َAdult females (age ≥18 years) with a histologically confirmed diagnosis of localized invasive breast carcinoma
Scheduled to receive adjuvant radiotherapy at least 50 Gy after breast surgery (breast-conserving surgery or mastectomy)
Exclusion criteria:
Prior history of radiotherapy to the treatment field
Inflammatory or metastatic breast carcinoma
Concurrent chemotherapy with RT (trastuzumab and hormonal therapy were allowed)
Generalized skin disorders
Connective tissue disorders
Untreated surgical wounds
Known allergy or hypersensitivity history to montelukast or any ingredients of the gel
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into 2 groups with the help of a computer-generated random assignment by an independent statistician who was not part of the study team. Allocation will be concealed using sequentially numbered opaque sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researchers, and radiooncologists will not be aware of the
patients’ allocated gel.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethnic Committees of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2022-01-16, 1400/10/26
Ethics committee reference number
IR.ZUMS.REC.1400.450
Health conditions studied
1
Description of health condition studied
Acute radiation dermatitis
ICD-10 code
L58.0
ICD-10 code description
Acute radiodermatitis
Primary outcomes
1
Description
The primary end point is to determine whether the montelukast gel can reduce the incidence of acute radiation dermatitis in comparison to placebo.
Timepoint
Patients will be evaluated for acute radiation dermatitis severity weekly after every fifth RT session.
Method of measurement
The severity of acute radiation dermatitis will be scored using the radiation therapy oncology group and the European organization for research and treatment of cancer (RTOG / EORTC ) criteria based on the clinical presentation.
Secondary outcomes
1
Description
The secondary outcomes are to assess if montelukast gel reduces radiotherapy-induced symptoms such as pain and moist desquamation and improves the skin-related quality of life as compared to placebo.
Timepoint
Patients will be evaluated for radiotherapy-induced symptoms such as pain and moist desquamation weekly after every fifth RT session. the patients will be requested to fill out the dermatology life quality index (DLQI) from considering their feelings during the past week.
Method of measurement
The size and severity of moist desquamation will be assessed by the common terminology criteria for adverse events ( CTCAE version 5.0 ) criteria based on the clinical presentation. The worst experienced pain will be evaluated using a visual analog scale. The skin-related quality of life of the patients was appraised using the Dermatology life quality index (DLQI) score.
Intervention groups
1
Description
Intervention group: montelukast gel
Category
Prevention
2
Description
Control group: placebo gel
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Monireh Maham
Street address
Valiasr Hospital, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Fax
Email
valiasr@zums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Monireh Maham
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy Faculty, Zanjan University of Medical Sciences, Dr. Soubuti Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 3635
Email
m.maham@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Monireh Maham
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy Faculty, Zanjan University of Medical Sciences, Dr. Soubuti Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 3635
Email
m.maham@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Monireh Maham
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy Faculty, Zanjan University of Medical Sciences, Dr. Soubuti Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 3635
Email
m.maham@zums.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