Use of sesame oil in the treatment of acute dermatitis caused by radiotherapy in breast cancer patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 40 patients. For randomization after registration of eligible patients, they are assigned to treatment groups (sesame oil and placebo) based on a random algorithm following the dynamic allocation procedure.
Settings and conduct
The study to evaluate the effectiveness of sesame oil on the complication of acute dermatitis caused by radiotherapy in non-metastatic female patients aged 18 to 75 years with breast cancer undergoing treatment in Babol University of Medical Sciences and patients will be randomly divided into 2 groups. One group will be treated with paraffin (as placebo) and the other group will be treated with sesame oil, which are equalized in terms of color, shape, consistency and odor, and placebo and sesame oil in the same and impossible dishes. In this study, patients and researchers were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-metastatic female patients aged 18 to 75 years with breast cancer who underwent lumpectomy; Completion of the chemistry cycle;
Exclusion criteria: active infection; vascular collagen diseases; previous history of radiotherapy
Intervention groups
Candidates will be randomly assigned to two groups. These patients receive either sesame oil (experimental group) or Vaseline (placebo group)
Main outcome variables
Radiotherapy dermatitis based on the staging system of the Radiation Oncology Group (RTOG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120707010205N9
Registration date:2021-07-11, 1400/04/20
Registration timing:registered_while_recruiting
Last update:2021-07-11, 1400/04/20
Update count:0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Dariush Moslemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1323 6752
Email address
d.moslemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-03, 1400/04/12
Expected recruitment end date
2021-08-03, 1400/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of sesame oil versus placebo in the management of acute radiation-induced dermatitis in breast cancer patients
Public title
The effectiveness of sesame oil in breast radiotherapy burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should complete the adjuvant chemotherapy before starting bilateral breast radiotherapy.
Non-metastatic female patients with breast cancer who underwent lumpectomy
Patients should be 18 to 75 years old
Exclusion criteria:
Patients with collagen-vascular diseases
Patients with a history of previous radiotherapy
Having an active infection during the study
Patients with allergies to sesame oil (or placebo)
Age
From 18 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, packages containing medicine or placebo are placed in the box as a mixture, and when offered to the candidates, without looking inside the box, one of the packages is randomly selected and given to the candidate. The package containing the placebo is marked with the letter A and the package containing the medicine is marked with the letter B.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, sesame and paraffin oils are completely identical in terms of color, shape, consistency and smell, and are placed in the same containers so that the contents of the containers are not visible in terms of shape, color and consistency for the researcher and the patient. Somehow it is planned that the participant and the researcher
They do not know which of the two control or test groups
Sesame or placebo oil is given.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences' Ethics Committee
Street address
Ganje-Afrouz St.
City
Babol
Province
Mazandaran
Postal code
4717641367
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.MUBABOL.REC.1400.165
Health conditions studied
1
Description of health condition studied
acute radiation-induced dermatitis in breast cancer patients
ICD-10 code
L58.9
ICD-10 code description
Radiodermatitis, unspecified
Primary outcomes
1
Description
score of acute dermatitis according to the staging system of the Radiation Oncology Group (RTOG)
Timepoint
At the beginning of the study (before the intervention) and 7, 14 and 21 and the last day after the start of sesame oil consumption
Method of measurement
RTOG criteria to evaluate acute skin reaction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sesame oil: After each session of radiotherapy, patients should use 3 cc of sesame oil in the breast area that has undergone radiotherapy so that the solution is spread evenly on the skin surface and apply sesame oil once after each radiotherapy Continue until the end of the radiotherapy course (30 sessions).
Category
Treatment - Drugs
2
Description
Control group: Placebo paraffin: After each radiotherapy session, patients should use 3 cc of placebo in the breast area undergoing radiotherapy so that the solution is evenly distributed on the skin surface and take placebo once until the end of the radiotherapy course. (30 sessions) Continue.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
dariush moslemi
Street address
Ayatollah Rouhani Hospital,ganj afroz ave,babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Mazandaran, Babol, Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dariush Muslimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Mazandaran, Babol, Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Dariush Moslemi
Position
Associated Assistant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Ganj afrooz Street
City
Babol
Province
Mazandaran
Postal code
4718798467
Phone
+98 11 3223 4707
Fax
Email
d.moslemi@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dariush Moslemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Devision of radiation oncology, Babol University of Medical Sciences, ganj afrooz street, babol, mazandaran, iran
City
Babol
Province
Mazandaran
Postal code
4717447745
Phone
+98 11 1222 4032
Fax
+98 11 1223 4367
Email
d.moslemi@mubabol.ac.ir
Web page address
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
There is no more information
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