The effect of melatonin supplementation on tumor grading, pathologic findings, serum levels of biomarkers related to inflammation and oxidative stress in patient with breast cancer
The aim of this study is to determine melatonin effect on tumor grading, pathologic findings, serum levels of biomarkers related to inflammation and oxidative stress in patient with breast cancer
40 patients with breast cancer referred to Shahid-Beheshti hospital will divided into two groups. 20 patients of control group will receive neoadjuvant chemotherapy plus placebo and 20 patients of intervention group will receive chemotherapy plus melatonin supplementation. At the beginning as well as end of intervention, tumor grade, pathological findings, serum levels of biomarkers related to inflammation and oxidative stresswill be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having breast cancer and over 25 years of age
Exclusion criteria: patients' death, liver and renal failure, inappropriate laboratory blood test
Intervention groups
Control group: patients will receive placebo in addition to standard treatment
Intervention group: patients will receive melatonin supplementation in addition to standard treatment
Main outcome variables
Tumor grade and pathological findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171105037262N5
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
mohammadhossein pourhanifeh
Name of organization / entity
kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 0988
Email address
pourhanifeh-mh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin supplementation on tumor grading, pathologic findings, serum levels of biomarkers related to inflammation and oxidative stress in patient with breast cancer
Public title
Evaluation of melatonin effect on breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having breast cancer at any stage undergoing neoadjuvant chemotherapy
Above 25 years of age
Exclusion criteria:
Having renal and liver failure
Abnormal blood test
Age
From 25 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by the website (https://stattrek.com/statistics/random-number-generator.aspx). Block randomization with 1:1 allocation ratio is applied to have equal group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants and researchers or outcomes evaluators are unaware of allocation of study groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical sciences
Street address
Ghotb-e-ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.054
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
Tumor grade
Timepoint
At the beginning and end of intervention
Method of measurement
Microscopic
Secondary outcomes
1
Description
Serum levels of biomarkers related to inflammation and oxidative stress
Timepoint
At the beginning and end of interventio
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Receiving chemotherapy and melatonin supplementation. Every night one hour prior to sleep, patients will orally receive two 5mg capsules of melatonin for 24 weeks. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery.
Category
Treatment - Drugs
2
Description
Control group: Receiving chemotherapy and placebo. Neoadjuvant chemotherapy regimen consist of 4 cycle doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 every 14_21 days followed by 4 cycle paclitaxel 175mg/m2 every 14-21 days. Four to six week after completion of neoadjuvant chemotherapy the patient will undergo surgery. Patients will orally receive two placebo capsules (barij essence, Iran) one hour prior to sleep for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid-Beheshti hospital
Full name of responsible person
Amirhassan Matini
Street address
Ghotb-e-ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
Matiniamir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Ghotb-e-ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
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
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotb-e-ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotb-e-ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
asemi_r@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Pourhanifeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghotb-e-ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 0988
Email
mhph.lord.1996@gmail.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