The effect of concurrent administration of melatonin and neoadjuvant chemotherapy on the pathological response in breast cancer patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 52 patients. Randomization will be done using STATA software and using random blocks.
Settings and conduct
Fifty-two patients with non-metastatic breast cancer who are candidates for neoadjuvant chemotherapy in Imam Reza and Ghaem hospitals are randomly divided into two intervention and control groups (26 people in each group).
Chemotherapy is performed similarly in the two groups.
The pathological response after surgery is compared in two groups.
Participants/Inclusion and exclusion criteria
1-Patients with stage one to three breast cancers
2- No previous history of chemotherapy
3-Absence of contraindications to neoadjuvant chemotherapy for breast cancer (including heart failure and drug allergies)
4- Age 30 to 60 years at the time of starting chemotherapy
5-Absence of uncontrolled diabetes, renal failure with glomerular filtration less than 30 and liver failure
Intervention groups
Intervention group:
Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy.
control group:
Patients in the control group are given one placebo tablet (similar to melatonin tablets) each night during a 5-month course of chemotherapy.
Main outcome variables
The pathological response after neoadjuvant chemotherapy is assessed according to the Chevallier system as follows:
1- Pathological complete response: Disappearance of all the tumor cells in breast and lymph nodes
2- Pathological partial response: Presence of invasive carcinoma with stromal alterations
3- Pathological no response: little modification in the original tumor appearance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200409047007N3
Registration date:2021-12-02, 1400/09/11
Registration timing:prospective
Last update:2021-12-02, 1400/09/11
Update count:0
Registration date
2021-12-02, 1400/09/11
Registrant information
Name
Mohsen Seddigh-Shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8818
Email address
seddighshamsim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients
Public title
The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with stage one to three breast cancers
Age 30 to 60 years at the time of starting chemotherapy
Exclusion criteria:
No previous history of chemotherapy
Absence of contraindications to neoadjuvant chemotherapy for breast cancer including heart failure and drug sensitivity
Absence of uncontrolled diabetes, renal failure with glomerular filtration less than 30 and liver failure
Age
From 30 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly placed in blocks of 6. In each block, 3 patients receive melatonin and 3 patients receive placebo and patients are placed in blocks in the order of enrollment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization was performed by Dr. Fazelipour and only she knows the type of medicine that is prescribed to each patient. The coded drug packages will be placed in the pharmacy next to the chemotherapy ward and will be delivered to each patient according to the code given to him. Patients, planners, physicians, and those who analyze the data are unaware of the type of medication each patient is receiving.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central University Building, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.252
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm: Breast, unspecified
Primary outcomes
1
Description
Pathological response
Timepoint
surgery after neoadjuvant chemotherapy
Method of measurement
The pathological response after neoadjuvant chemotherapy is assessed according to the Chevallier system as follows:1- Pathological complete response: Disappearance of all the tumor cells in breast and lymph nodes2- Pathological partial response: Presence of invasive carcinoma with stromal alterations3- Pathological no response: little modification in the original tumor appearance.
Secondary outcomes
1
Description
Quality of life
Timepoint
At beginning and end of chemotherapy
Method of measurement
EORTC QLQ – BR23 questionnaire
Intervention groups
1
Description
Intervention group: Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group are given one placebo tablet (similar to melatonin tablets) each night during a 5-month course of chemotherapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Afshin Imani
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
imani_afshin@yahoo.com
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Afshin Imani
Street address
Department of Internal Medicine, Ghaem Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
imani_afshin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Deputy of Research and Technology, Central University Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 3557
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh Shamsi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh-Shamsi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
009851385988188
Email
seddighshamsim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh-Shamsi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
009851385988188
Email
seddighshamsim@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After collecting and analyzing the data, the results will be made available to the public in the form of articles.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Physicians
Under which criteria data/document could be used
There are no restrictions
From where data/document is obtainable
Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science
What processes are involved for a request to access data/document