Comparing the effectiveness of melatonin administration compared to placebo on fatigue in breast cancer patients
Design
Clinical trial with a control group; Triple-blinded, randomized, with parallel group, phase 3 on 100 patients. Patients were randomly assigned to one of the two groups under study using a table of random numbers 1:1 blocks will be imported.
Settings and conduct
This clinical trial will be conducted in the radiation oncology department of Namazi Hospital affiliated to Shiraz University of Medical Sciences. The method of implementation of the plan will be that patients with breast cancer, if they are eligible to enter the study (based on inclusion and exclusion criteria), after obtaining informed written consent, will be randomly treated with melatonin 20 mg every night or placebo during adjuvant treatment. The patient, the attending physician, as well as the person who evaluates the side effects of the treatment will be blinded to the study group, and only someone outside the research team (pharmacologist who prepares the drugs) will be blinded to which drug group and which placebo group. will receive will be aware.
Participants/Inclusion and exclusion criteria
Entry requirements: newly diagnosed breast cancer patients who are candidates for adjuvant radiotherapy.
non-entry: patients who have a history of previous cancer or previous radiotherapy and not functionally suitable or do not have the necessary cooperation.
Intervention groups
Melatonin group: patients take 20mg Melatonin every night concurrent with RT.
Placebo group: patients take Placebo every night concurrent with RT.
Main outcome variables
Average fatigue score in melatonin group before intervention; Average fatigue score in placebo group before the intervention; Average fatigue score in melatonin group after the intervention; Average fatigue score in placebo group after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220907055912N1
Registration date:2023-02-07, 1401/11/18
Registration timing:prospective
Last update:2023-02-07, 1401/11/18
Update count:0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Sadaf Sadeghi Yazdankhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 4696
Email address
ssadeghiy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Melatonin with placebo on radiation induced fatigue in breast cancer patients
Public title
Effect of Melatonin on radiation induced fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years old
Performance status KPS≥70 (یا ECOG score=0-1)
Newly diagnosed breast cancer patient
Indication of adjuant chemotherapy
Indication of adjuant radiotherapy
AC-T chemotherapy regimen
Exclusion criteria:
Lack of consent to participate in the study
Kidney, Heart and Liver chronic disease
History of previous malignant disease
History of previous Radiation therapy
Metastasis at presentation
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the two studied groups using a random number table with 1:1 blocks. It will be tried to ensure that the patients are the same in terms of age, gender, performance level, presence of underlying disease, and level of quality of life and fatigue before the study. Medicine and placebo (which are similar to medicine in terms of shape, appearance, consistency and smell) will be placed in the same container and marked with A and B codes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the attending physician, as well as the person who evaluates the side effects of the treatment will be blinded to the study group; and only someone outside the research team (pharmacologist who prepares the drugs) will be aware of which group receive drug and which group receive placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of medical sciences
Street address
Apartment c42, Almas shahr tower, Pezeshkan street, Moaliabad street
City
Shiraz
Province
Fars
Postal code
71876-41331
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.sums.med.rec.1400.604
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
Fatigue score in MIF questionnaire and stress score in BDI
Intervention group: In this group, patients take two 10 mg melatonin tablets every night during radiation therapy. Melatonin drug is prepared from Jalinous pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients take two placebo pills every night during radiation therapy. The placebo was prepared from Jalinous pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Ahmad mosalaei
Street address
Namazi square, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3647 4332
Email
namazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali eskandari
Street address
Shiraz university of medical sciences central building, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
70
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
Shiraz University of Medical Sciences
Full name of responsible person
Sadaf Sadeghi yazdankhah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No c42, Almas shahr tower, Pezeshkan street, Moaliabad street
City
Shiraz
Province
Fars
Postal code
71876-41331
Phone
+98 71 3638 0193
Email
ssadeghiy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sadaf Sadeghi yazdankhah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No c42, Almas shahr tower, Pezeshkan street, Moaliabad street
City
Shiraz
Province
Fars
Postal code
71876-41331
Phone
+98 71 3638 0193
Email
ssadeghiy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sadaf Sadeghi yazdankhah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No c42, Almas shahr tower, Pezeshkan street, Moaliabad street
City
Shiraz
Province
Fars
Postal code
71876-41331
Phone
+98 71 3638 0193
Email
ssadeghiy@yahoo.com
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