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The effect of olive oil and calcium hydroxide emulsion on radiation radiation-induced dermatitis in breast cancer patients referred to Adjuvant RadiationTherapy

Protocol summary

Study aim
Determining the effect of olive oil and calcium hydroxide emulsion in reducing radiation dermatitis caused by radiotherapy in breast cancer patients who are candidates for adjuvant radiotherapy who were transferred to Parsian Shahrekord Center.
Design
Two-blind clinical trial on 120 female patients and randomly divided into four groups using the relevant software.
Settings and conduct
The patients are divided into four groups of 20 people by random assignment method. The medicine is placed in the breast, supraclavicular and axillary surgery site of the same side 30 minutes before the start of radiation therapy. All the products used in the study are completely identical in appearance and packaging, and their contents are indicated by labels in English letters.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 20 to 80 years who have undergone breast tumor surgery and are indicated for adjuvant radiotherapy. The pathology is breast invasive carcinoma. Patients who have a mass larger than 5 cm and at least one lymph node are involved and have a lumen. Pre-menopausal and post-menopausal age. Do not use any other topical medication during treatment. Exclusion criteria: diabetic patients and those with inflammatory breast carcinoma. People with known allergies to olive oil and calcium hydroxide. Those with scleroderma or disease They have lung parenchyma.
Intervention groups
First group: routine radiotherapy treatment + olive oil Second group: routine radiotherapy + olive oil along with calcium hydroxide The third group: routine radiotherapy treatment + castor oil Fourth group: routine treatment of radiotherapy + castor oil with calcium hydroxide
Main outcome variables
radiation-induced dermatitis (erythema, dry desquamative, wet desquamative, necrosis)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210614051571N1
Registration date: 2023-06-07, 1402/03/17
Registration timing: registered_while_recruiting

Last update: 2023-06-07, 1402/03/17
Update count: 0
Registration date
2023-06-07, 1402/03/17
Registrant information
Name
Reyhaneh Habibiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
st-habibiyan.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olive oil and calcium hydroxide emulsion on radiation radiation-induced dermatitis in breast cancer patients referred to Adjuvant RadiationTherapy
Public title
Investigating the effect of emulsion containing olive oil and calcium in reducing radiation dermatitis caused by radiotherapy in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20 to 80 years who have undergone breast tumor surgery and are indicated for adjuvant radiotherapy (both MRM and BCS) Its pathology type is invasive breastbe carcinoma Patients with a mass larger than 5 cm and at least one lymph node involved and lampooning Menopausal premenopause and postmenopausal age Do not use any other topical medication during treatment
Exclusion criteria:
Diabetic patients Those with inflammatory breast carcinoma. People with known allergies to olive oil and calcium hydroxide. People with scleroderma or lung parenchymal disease.
Age
From 20 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In order to better manage the implementation of the experiment and the number of samples in the groups, the random block method is used. For this purpose, the eligible conditions for entering the study were assigned to groups A, B, C, and D, respectively, by random and random block method in blocks of eight people. We considered the number of samples in each block to be twice the number of groups, considering that the sample volume was equal to 120 people, for this purpose, 15 envelopes were prepared and we named them in order from number 1 to 15. Each envelope had eight identical cards. . Two cards were randomly assigned to each group and group labels with letters A, B, C and D were inserted on them. At the time of entering the study, the envelopes were opened in order and a card from abroad, the letter named on the card, showed the specific group of the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since all the products used in the study are completely identical in terms of appearance and packaging and are inside non-transparent sprayers, and their contents are indicated by the label with English letters by the pharmacologist and using rose essence according to the pharmacologist's opinion. are the same, residents and patients do not have any information about the content inside the nebulizer.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.SKUMS.REC.1400.058

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
Radiation-induced dermatitis (erythema, dry desquamative, wet desquamative, necrosis)
Timepoint
At the beginning of the study and then at the end of the first, second, third and fourth week.
Method of measurement
RTOG questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: routine radiotherapy treatment + castor oil, which is sprayed on the target area half an hour before radiotherapy, like other groups.
Category
Treatment - Drugs

2

Description
Intervention group: Routine treatment of radiotherapy + olive oil ointment 10 mm half an hour before the start of radiotherapy for 28 sessions
Category
Treatment - Drugs

3

Description
Intervention group: routine radiotherapy treatment + olive oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Darman company and with a percentage of 3%.
Category
Treatment - Drugs

4

Description
Intervention group: Routine radiotherapy treatment + castor oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Derman company and with a percentage of 3%
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Parsian Hospital
Full name of responsible person
Rouh allah Maasoumi
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
St-habibiyan.r@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
St-habibiyan.r@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Reyhaneh Habibiyan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
St-habibiyan.r@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reyhaneh Habibiyan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
St-habibiyan.r@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reyhaneh Habibiyan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
St-habibiyan.r@skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2021-2022
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
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