Protocol summary
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Study aim
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Determination of radiation-induced skin burns of breast cancer patients in two groups receiving nano-corcumin capsules and control
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Design
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Two arm randomised trial, triple blinded, Phase 3 on 42 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention with administration of nano-curcumin capsules and control without prescription
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Main outcome variables
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The amount of radiation induced skin reaction
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2020-06-12, 1399/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-12-05, 1399/09/15
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Actual recruitment start date
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2020-09-06, 1399/06/16
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Actual recruitment end date
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2020-12-13, 1399/09/23
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Trial completion date
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2021-01-24, 1399/11/05
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Scientific title
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Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
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Public title
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Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
42
Actual sample size reached:
42
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-18, 1399/01/30
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1399.001
Health conditions studied
1
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Description of health condition studied
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Radiation induced skin reactions
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ICD-10 code
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L58.0
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ICD-10 code description
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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
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Description
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skin burn grade
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Timepoint
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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
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Method of measurement
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Determination of skin reaction (skin burn grade) according to the criteria of the Radiotherapy-Oncology group by a radiation oncologist
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: No medication
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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98227
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The documents include tables of the recovery process of patients who have used the medication.
All potential data can be shared after blinding.
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When the data will become available and for how long
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Start of access period: 6 months after the publication of the results.
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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