Effect of Melatonin on reduction of the radiation dermatitis grade Ⅲ in breast cancer patients
Design
Randomized triple-blinded clinical trial with control group، phase 3
Settings and conduct
Randomization process will be performed in block size of 4 by online internet website of randomization "Sealed Envelope Ltd" available from https://www.sealedenvelope.com. The patients will be andomly assigned to Placebo or Melatonin groups. Allocation of codes will be blinded. The main researcher will enroll the participants based on the inclusion criteria according to the codes. The patients will take 20 mg tablet of Melatonin or Placebo from first fraction to two weeks after the last radiotherapy fraction every night. Patients will be evaluated by physician weekly and compared for severity of radiodermatitis and the frequency of radiodermatitis grade three.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Female patients aged over 18 years old of breast cancer (stage I-Ⅲ) who had lumpectomy or mastectomy and completed chemotherapy at least 4 weeks prior to the study. The patients will undergo the convectional radiotherapy regimen with daily fraction of 2 Gy.
Exclusion Criteria: Pregnancy, breast feeding, epilepsy, serious liver dysfunction, untreated mental illnesses, diabetes mellitus type 1 or 2, uncontrolled hypertension, concurrent immunosuppressive treatments, connective tissue disorders, history of thoracic radiotherapy, asthma or severe allergic reactions, allergy to Melatonin, coagulopathy, taking sedatives or anticoagulants
Intervention groups
Two 20-member groups of intervention and placebo will take 20mg of melatonin or placebo tablet every night from the first night of the first fraction to two weeks after the last fraction of radiotherapy regimen.
Main outcome variables
Radiation dermatitis grade Based on the standard grading criteria of CTCAE version 4.03)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231218060453N1
Registration date:2023-12-31, 1402/10/10
Registration timing:prospective
Last update:2023-12-31, 1402/10/10
Update count:0
Registration date
2023-12-31, 1402/10/10
Registrant information
Name
Fatemeh Pakniyat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2540
Email address
fpakniat84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Melatonin on Reduction of the Grade Three Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial
Public title
Melatonin and Reduction of the Radiation Dermatitis in Breast Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged above 18 years old with breast cancer diagnosis (stage I-Ⅲ)
Previous surgery (lumpectomy or mastectomy)
Completion of chemotherapy 4 weeks prior to study entry (if it was prescribed for the patient)
Radiotherapy regimen with fractionation daily dose of 2 Gy
Exclusion criteria:
Pregnancy
Breast-feeding
Serious functional disorders of the liver
Epilepsy
Diabetes mellitus type 1 or 2
Uncontrolled hypertension
Concurrent connective tissue disorders
History of chest radiation radiotherapy
History of asthma or severe allergic reactions
Blood coagulation disorders
Concurrent immunosuppressive treatments
Taking sedative or anticoagulant drugs at the same time
Sensitivity to melatonin
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization process will be performed in block sizes of 4 to balance the number of allocated samples. This process will be done by online internet website of randomization (Sealed Envelope Ltd) available from https://www.sealedenvelope.com
and the patients will be randomly assigned to the control (placebo) or intervention (Melatonin) groups with a one-to-one correspondence. Allocation of codes will be blinded. Patients will be enrolled in the study according to the codes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Numbers of randomization process will be placed in the opaque, sealed envelopes with the randomized numbers printed on them. The envelopes will be kept by the blind staff. Allocation of codes will be related to the Melatonin or Placebo and saved in the confidential folder.
People involved in the trial including participants(patients), principal investigators, healthcare providers (Physicians, nurses, secratories etc.), family of patients who care for patients during the trial, data collectors, and outcome assessors and data safety and monitoring board do not know if the recipient is receiving the actual drug or placebo and all of them are blinded. Melatonin tablets 20 mg from Jalinous Pharmaceutical company in both intervention and placebo groups are completely similar in terms of color, shape, smell, size and method of administration. Drugs will be delivered to patient as A or B in the same shape, and nobody knows which of them is true drug and which of them is placebo.
Determination of the grade of radiation dermatitis through direct inspection by physician from the beginning of the study to two weeks after the last radiotherapy fraction weekly
Method of measurement
Based on the standard grading criteria of CTCAE (Common Toxicity Criteria for Adverse Events, version 4.03) for cancer clinical trials
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy who take 20 milligram tablet of melatonin every night from first fraction to two weeks after last radiotherapy fraction.
Category
Treatment - Drugs
2
Description
Control group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy regimen take one tablet of placebo every night from first fraction to two weeks after last radiotherapy fraction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Ward of Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Mona Malekzadeh
Street address
Shahrdari Street, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Seyedeh Mehri Hamidi
Street address
hahid Beheshti University, Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2761
Email
m_hamidi@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Shafaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital. Daar-abad Street. Niavaran Ave.
City
Tehran
Province
Tehran
Postal code
19575154
Phone
+98 21 2712 3000
Email
shafaghishadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Pakniyat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Masih Daneshvari Hospital. Daar-abad Street. Niavaran Ave.
City
Tehran
Province
Tehran
Postal code
19575154
Phone
+98 21 2712 2175
Email
fpakniat84@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rojan Shokoohizadeh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Nom 47, Kohestan 3, Alborz town
City
Tehran
Province
Tehran
Postal code
1955673611
Phone
+98 21 2246 6595
Email
rozhanshokouhi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some images of skin regions with radiodermatitis will be published without revealling patients identity.
When the data will become available and for how long
After publishing results
To whom data/document is available
Allowed for the public
Under which criteria data/document could be used
Extracting the data of this study data for further investigations in this regard is allowed with citing.
From where data/document is obtainable
Studying an article after publication or communicating with the corresponding author via email address of fpakniat84@gmail.com
What processes are involved for a request to access data/document
Communicating with the corresponding author via email address of fpakniat84@gmail.com