Comparative determination of the effect of Linora spray compared to the control group in patients with breast cancer treated with conformal radiotherapy.
Design
In this research, 60 breast cancer patients who have undergone partial mastectomy and are going to undergo radiotherapy are included in the study and divided into intervention and control groups using SPSS software. After the visit of each patient who meets the entry criteria, an envelope is removed and according to the code written in it (for example, A/B), the patient is placed in one of two groups. Both groups are subjected to the same radiotherapy. The study has parallel and double-blind groups, and the person who analyzes the clinical results and the statistical analyst of the intervention group and the blind control will be.
Settings and conduct
The study is a randomized controlled clinical trial and is double-blind and parallel. The place of study is Seyed Al Shahada (Omid) Hospital, Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Breast cancer patients who underwent partial mastectomy and are supposed to undergo conformal breast radiotherapy and levels one, two and three and supraclave with a dose of 45 to 50 Gy and a boost of 60 Gy to the primary tumor bed.
Exit criteria:
In case of allergy to the spray
Intervention groups
For the intervention group, at the time of starting radiotherapy, hydrocortisone ointment and Linora spray are applied to the place of radiotherapy for 2 times a day.
Main outcome variables
Skin complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201203049585N4
Registration date:2024-03-30, 1403/01/11
Registration timing:registered_while_recruiting
Last update:2024-03-30, 1403/01/11
Update count:0
Registration date
2024-03-30, 1403/01/11
Registrant information
Name
Nadia Najafizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 2366
Email address
nadianajafizade@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Linora spray compared to the control group in patients with breast cancer treated with conformal radiotherapy
Public title
A comparative study of the effect of Linora spray compared to the control group in patients with breast cancer treated with conformal radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer patients who underwent partial mastectomy
Radiotherapy candidates are breast and lymph nodes
Exclusion criteria:
In case of allergy to the spray
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, breast cancer patients who have undergone partial mastectomy and are going to undergo radiotherapy are included in the study. Using SPSS software version 20, they are divided into two intervention and control groups. The assigned codes are written separately on separate sheets and placed inside separate envelopes or the sheet is folded in such a way that the code written inside cannot be seen. After each patient meets the entry criteria, an envelope is removed and according to the code written in it (for example, A/B), the patient is placed in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. Patients are divided into intervention and control groups. The assigned codes are written separately on separate sheets and placed in separate envelopes. After the visit of each patient who meets the entry criteria, an envelope is removed and according to the code written in it (for example, A/B), the patient is placed in one of two groups. The outcome assessor and the researcher also perform the visit in terms of skin burn rate during radiotherapy without knowing about the drug used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazarjarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184917911
Approval date
2022-09-27, 1401/07/05
Ethics committee reference number
IR.MUI.MED.REC.1401.243
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
Reduction of radiotherapy burn complications in breast cancer patients
Timepoint
The patients under study are examined in order to check the skin reactions in the first, third and end of the radiotherapy treatment.
Method of measurement
The rate of skin reactions in people participating in this study is evaluated using the classification of world class skin complications of radiotherapy complications.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, at the time of starting radiotherapy, hydrocortisone ointment and Linora spray are applied to the place of radiotherapy for 2 times a day.
Category
Rehabilitation
2
Description
Control group: In the control group, hydrocortisone ointment treatment is prescribed at the site of radiotherapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Nadia najafizadeh
Street address
Motahari Street, Omid Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3236 8006
Email
nadianajafizade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
sfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 0416
Email
Haghjoo@med.Mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Motahari Street, Shiri Bridge, Seyed Al Shahada Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Email
Nadianajafizade@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Motahari Street, Shiri Bridge, Seyed Al Shahada Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Email
Nadianajafizade@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Motahari Street, Shiri Bridge, Seyed Al Shahada Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3775 2366
Email
Nadianajafizade@med.mui.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