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Protocol summary
The present study will be done on patients undergoing breast cancer radiotherapy referred to the Yasrebi Hospital, Kashan, Iran in 2020-2021. The patients will be treated with standard radiotherapy regimen of one fraction per day, 5 days a week, 25 treatment fractions (5 weeks), radiation dose per faction of 200 cGy and a total radiation dose of 5000 cGy. The patients will take Nano-curcumin capsules in order to reduce radiation-induced skin reactions. 42 patients with easy sampling were entered and divided by a mixture of 2 and 4 randomized blocks into two groups of control and treated with Nano-curcumin. The patient will be unaware of the type of medication prescribed.The control group will only receive a standard radiotherapy regimen and treatment group will receive a standard radiotherapy regimen plus Nano-curcumin. The patients will receive Nano-curcumin from the first fraction of radiotherapy and continue until the end of the treatment. Finally, skin evaluation of patients will be done weekly by a radiation oncologist.
The present study will be done on patients undergoing breast cancer radiotherapy referred to the Yasrebi Hospital,Kashan, Iran in 2020-2021. The patients will be treated with a standard radiotherapy regimen of one fraction per day, 5 days a week, 25 treatment fractions(5 weeks), radiation dose per fraction of 200 cGy and a total radiation dose of 5000 cGy. The patients will take Nano-curcumin capsules in order to reduce radiation-induced skin reactions. 42 patients with easy sampling were entered and divided by a mixture of 2 and 4 randomized blocks into two groups of control and treated with nano-curcumin.The patient will be unaware of the type of medication prescribed.The control group will only receive a standard radiotherapy regimen and the treatment group will receive a standard radiotherapy regimen plus Nano-curcumin.The patients will receive nano-curcumin from the first fraction of radiotherapy and continue until the end of the treatment.Finally,skin evaluation of patients will be done weekly by a radiation oncologist.
The present study will be done on patients undergoing breast cancer radiotherapy referred to the Yasrebi Hospital, KashanHospital,Kashan, Iran in 2020-2021. The patients will be treated with a standard radiotherapy regimen of one fraction per day, 5 days a week, 25 treatment fractions (5fractions(5 weeks), radiation dose per factionfraction of 200 cGy and a total radiation dose of 5000 cGy. The patients will take Nano-curcumin capsules in order to reduce radiation-induced skin reactions. 42 patients with easy sampling were entered and divided by a mixture of 2 and 4 randomized blocks into two groups of control and treated with Nanonano-curcumin. Thecurcumin.The patient will be unaware of the type of medication prescribed.The control group will only receive a standard radiotherapy regimen and the treatment group will receive a standard radiotherapy regimen plus Nano-curcumin. Thecurcumin.The patients will receive Nanonano-curcumin from the first fraction of radiotherapy and continue until the end of the treatment. Finally, skintreatment.Finally,skin evaluation of patients will be done weekly by a radiation oncologist.
General information
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42
42
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2020-09-06, 1399/06/16
2020-09-06 00:00:00
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2020-12-13, 1399/09/23
2020-12-13 00:00:00
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2021-01-24, 1399/11/05
2021-01-24 00:00:00
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End the trial
Record the date of onset of the disease
Record the end date of the patient
Record the end date of the trial
Convert Nano-curcumin to nano-curcumin
Correct the English title of the trial
Extending the age range of the studied patients from 70 to 80 years
End the trial Record the date of onset of the disease Record the end date of the patient Record the end date of the trial Convert Nano-curcumin to nano-curcumin Correct the English title of the trial Extending the age range of the studied patients from 70 to 80 years
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خاتمه یافتن ترایال
ثبت تاریخ آغاز بیمارگیری تحقق یافته
ثبت تاریخ پایان بیمارگیری تحقق یافته
ثبت تاریخ پایان ترایال
تبدیل Nano-curcumin به nano-curcumin
تصحیح عنوان انگلیسی ترایال
گسترش بازه سن بیماران مورد مطالعه از 70 به 80 سال
خاتمه یافتن ترایال ثبت تاریخ آغاز بیمارگیری تحقق یافته ثبت تاریخ پایان بیمارگیری تحقق یافته ثبت تاریخ پایان ترایال تبدیل Nano-curcumin به nano-curcumin تصحیح عنوان انگلیسی ترایال گسترش بازه سن بیماران مورد مطالعه از 70 به 80 سال
Assessment of effect of Nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients
Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
AssessmentEffect of effect of Nanonano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
Assessment of effect of Nano-Curcumin on radiotherapy-induced skin reaction in breast cancer patients
Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
AssessmentEffect of effect of Nanonano-Curcumincurcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
Simple randomization
42 patients referred to the Yasrebi radiotherapy center will enter the study with easy sampling. These individuals are then divided into two groups of control and treated with curcumin using a mixture of 2 and 4 randomized blocks.
Simple randomization
42 patients referred to the Yasrebi radiotherapy centre will enter the study with easy sampling. These individuals are then divided into two groups of control and treated with nano-curcumin using a mixture of 2 and 4 randomized blocks.
Simple randomization 42 patients referred to the Yasrebi radiotherapy centercentre will enter the study with easy sampling. These individuals are then divided into two groups of control and treated with nano-curcumin using a mixture of 2 and 4 randomized blocks.
تصادفی سازی ساده
42 نفر از بیماران مراجعه کننده به بخش رادیوتراپی بیمارستان آیت اله یثربی به صورت نمونه گیری آسان وارد مطالعه خواهند شد. سپس این افراد با استفاده از مخلوطی از بلوکهای تصادفی 2 و 4 تایی به دو دسته شاهد و درمان با داروی کورکومین تقسیم بندی می شوند.
تصادفی سازی ساده
42 نفر از بیماران مراجعه کننده به بخش رادیوتراپی بیمارستان آیت اله یثربی به صورت نمونه گیری آسان وارد مطالعه خواهند شد. سپس این افراد با استفاده از مخلوطی از بلوکهای تصادفی 2 و 4 تایی به دو دسته شاهد و درمان با داروی نانوکورکومین تقسیم بندی می شوند.
تصادفی سازی ساده 42 نفر از بیماران مراجعه کننده به بخش رادیوتراپی بیمارستان آیت اله یثربی به صورت نمونه گیری آسان وارد مطالعه خواهند شد. سپس این افراد با استفاده از مخلوطی از بلوکهای تصادفی 2 و 4 تایی به دو دسته شاهد و درمان با داروی کورکومیننانوکورکومین تقسیم بندی می شوند.
Primary outcomes
#1
Determination of skin reactionس at the beginning of study (before the intervention), 7, 14, 21, 28 and 35 days after the start of Nano-curcumin capsule consumption
Determination of skin reactionس at the beginning of the study (before the intervention), 7, 14, 21, 28 and 35 days after the start of nano-curcumin capsule consumption
Determination of skin reactionس at the beginning of the study (before the intervention), 7, 14, 21, 28 and 35 days after the start of Nanonano-curcumin capsule consumption
تعیین درجه واکنش پوستی (گرید سوختگی ) بر اساس معیار انجمن رادیوتراپی -آنکولوژی توسط متخصص پرتودرمانی
تعیین درجه واکنش پوستی (گرید سوختگی ) بر اساس معیار انجمن رادیوتراپی - آنکولوژی توسط متخصص پرتودرمانی
تعیین درجه واکنش پوستی (گرید سوختگی ) بر اساس معیار انجمن رادیوتراپی -آنکولوژی توسط متخصص پرتودرمانی
Intervention groups
#1
Intervention group: Nano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule , one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction.
Intervention group: nano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule, one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction.
Intervention group: Nanonano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule, one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction.
Protocol summary
Study aim
Determination of radiation-induced skin burns of breast cancer patients in two groups receiving nano-corcumin capsules and control
Design
Two arm randomised trial, triple blinded, Phase 3 on 42 patients.
Settings and conduct
The present study will be done on patients undergoing breast cancer radiotherapy referred to the Yasrebi Hospital,Kashan, Iran in 2020-2021. The patients will be treated with a standard radiotherapy regimen of one fraction per day, 5 days a week, 25 treatment fractions(5 weeks), radiation dose per fraction of 200 cGy and a total radiation dose of 5000 cGy. The patients will take Nano-curcumin capsules in order to reduce radiation-induced skin reactions. 42 patients with easy sampling were entered and divided by a mixture of 2 and 4 randomized blocks into two groups of control and treated with nano-curcumin.The patient will be unaware of the type of medication prescribed.The control group will only receive a standard radiotherapy regimen and the treatment group will receive a standard radiotherapy regimen plus Nano-curcumin.The patients will receive nano-curcumin from the first fraction of radiotherapy and continue until the end of the treatment.Finally,skin evaluation of patients will be done weekly by a radiation oncologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Breast cancer patients who will undergo radiotherapy.
Exclusion criteria: Patients with previous breast cancer radiotherapy; Bilateral breast cancer; Concurrent chemotherapy; Tacking anticoagulants medications; Skin conditions or sensitivity to formulations; treated with an anti-epidermal growth factor receptor or partially irradiated; with diagnosis of inflammatory breast cancer; breast reconstruction
Intervention groups
Intervention with administration of nano-curcumin capsules and control without prescription
Main outcome variables
The amount of radiation induced skin reaction
General information
Reason for update
End the trial
Record the date of onset of the disease
Record the end date of the patient
Record the end date of the trial
Convert Nano-curcumin to nano-curcumin
Correct the English title of the trial
Extending the age range of the studied patients from 70 to 80 years
Acronym
IRCT registration information
IRCT registration number:IRCT20200513047427N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:1
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Tamara Talakesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 5138
Email address
tamara.talakesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
2020-09-06, 1399/06/16
Actual recruitment end date
2020-12-13, 1399/09/23
Trial completion date
2021-01-24, 1399/11/05
Scientific title
Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
Public title
Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer patients who will undergo radiotherapy.
Exclusion criteria:
Patients whose breast region have previously been irradiated.
Patients with bilateral breast cancer.
Patients receiving concurrent chemotherapy and radiotherapy
Patients taking anticoagulants such as warfarin (Coumadin) or heparin
Patients with skin conditions (such as bleeding, ulcers or incurable wounds) or sensitivity to formulations
Patients treated by anti-epidermal growth factor (EGRF)
Patients undergoing minor radiation to the breast area
Patients with special skin allergies
Patients with diagnosis of inflammatory breast cancer and reconstructive treatment
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
42 patients referred to the Yasrebi radiotherapy centre will enter the study with easy sampling. These individuals are then divided into two groups of control and treated with nano-curcumin using a mixture of 2 and 4 randomized blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding is done in such a way that patients, physicians, and data analysts are unaware of the type of intervention involved, and only the person who assigns the medication and control to patients is aware of the type of treatment.Patients are blinded by taking placebo.The treating physician treats and cares for patients without knowing the type of medication.The clinician who is responsible for evaluating the outcome reports her observations without knowing which patient has taken the placebo and which patient is taking the main medication.The data analyzer also receives data as A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research,Faculty of Nursing & Midwifery, Faculty of Health & Faculty of Paramedi
Street address
5th of Qotb –e Ravandi Blvd., Pezeshk Blvd., faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.001
Health conditions studied
1
Description of health condition studied
Radiation induced skin reactions
ICD-10 code
L58.0
ICD-10 code description
A radiation burn is damage to the skin or other biological tissue caused by exposure to radiation. The radiation types of greatest concern are thermal radiation, radio frequency energy, ultraviolet light and ionizing radiation.
Primary outcomes
1
Description
skin burn grade
Timepoint
Determination of skin reactionس at the beginning of the study (before the intervention), 7, 14, 21, 28 and 35 days after the start of nano-curcumin capsule consumption
Method of measurement
Determination of skin reaction (skin burn grade) according to the criteria of the Radiotherapy-Oncology group by a radiation oncologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule, one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction.
Category
Prevention
2
Description
Control group: No medication
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy center, Yasrebi Hospital
Full name of responsible person
Mostafa Sarvizadeh
Street address
Parastar Blvd., Ghotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715973454
Phone
+98 31 5558 5000
Fax
+98 31 5562 1530
Email
info@yasrebihospital.ir
Web page address
http://yasrebihospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Pezeshk Blv., Qotb–e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
98227
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Tamara Talakesh
Position
M.Sc. student
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
No.16, 15th Ave., Mirzay -e- shirazi St.
City
Tehran
Province
Tehran
Postal code
1586633813
Phone
+98 21 8831 5138
Fax
Email
tamara.talakesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Bagher Farhood
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Pezeshk Blvd., Ghotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 8883
Fax
+98 31 5554 8883
Email
bffarhood@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Tamara Talakesh
Position
M.Sc. student
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
No.16, 15th Ave., Mirzay -e- shirazi St.
City
Tehran
Province
Tehran
Postal code
1586633813
Phone
+98 21 8831 5138
Email
tamara.talakesh@gmail.com
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
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The documents include tables of the recovery process of patients who have used the medication.
All potential data can be shared after blinding.
When the data will become available and for how long
Start of access period: 6 months after the publication of the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of analysis and mechanism to improve and increase the well-being of patients and the development of science in accordance with ethical standards and protect the rights of researchers in this trial and not to distort the data.
From where data/document is obtainable
Department of Medical Physics and Radiology, Faculty of Paramedical Sciences, Kashan University of Medical Sciences, Kashan, Iran
Dr. Bagher Farhood, Email: bffarhood@gmail.com
Tamara Talakesh, Email: tamara.talakesh@gmail.com
What processes are involved for a request to access data/document
The request must be sent in writing or by e-mail, and after review by the research team and the observance of ethical and legal conditions, it is agreed to send the data.