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A study on the effects of melatonin supplementation in improving chemotherapy-induced fatigue in breast cancer patients over 50 years old

Protocol summary

Study aim
Determining the effect of melatonin supplementation on improving chemotherapy-induced fatigue in breast cancer patients over 50 years old
Design
Multi-center two-arm phase 3 parallel group randomised trial with blinded postoperative care and outcome assessment planed for 72 patients
Settings and conduct
In oncology clinics, interventionally, double-blind, with explanation, and obtaining informed consent from the patient, alongside standard treatment
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Informed consent to participate in the study. Breast cancer patients over 50 years old who require adjuvant or neoadjuvant chemotherapy. Patients with a functional level of 0 or 1 based on ECOG PS questionnaire. Exclusion Criteria: Patients with known underlying diseases that can exacerbate fatigue Use of sleep aids or fatigue-improving medications before the start of the intervention. Unwillingness to continue participation in the study. Lifestyle that interferes with the nocturnal sleep rhythm. Previous history of chemotherapy. Diagnosis of metastasis. Development of severe toxicities that cannot be controlled with standard doses, such as nausea
Intervention groups
Each patient in the intervention group will receive 5 mg of melatonin daily, starting one week before the initiation of chemotherapy and continuing for one month after its completion, while the control group will receive a placebo.
Main outcome variables
The mean score of chemotherapy-induced fatigue in breast cancer patients over 50 years old in the intervention and control groups before the intervention, after the completion of chemotherapy, and one month after chemotherapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250314065072N1
Registration date: 2025-03-23, 1404/01/03
Registration timing: prospective

Last update: 2025-03-23, 1404/01/03
Update count: 0
Registration date
2025-03-23, 1404/01/03
Registrant information
Name
shervin mashreghi moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 9335
Email address
bdmashreghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on the effects of melatonin supplementation in improving chemotherapy-induced fatigue in breast cancer patients over 50 years old
Public title
A study on the effects of melatonin supplementation in improving chemotherapy-induced fatigue in breast cancer patients over 50 years old
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed Consent for Study Participation Patients with breast cancer over 50 years old who require adjuvant or neoadjuvant chemotherapy. Patients with a functional level of 0 or 1 based on the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire.
Exclusion criteria:
Patients with known underlying conditions including uncontrolled diabetes, uncontrolled high blood pressure, cardiovascular diseases and heart failure, chronic kidney disease, chronic liver disease, autoimmune disease, obstructive respiratory disease, uncontrolled thyroid disorder, history of stroke, seizures, and mental disorder requiring medication. Use of sleep aids or fatigue-reducing medications prior to the start of the intervention. Unwillingness to continue cooperation in the study. Lifestyle that interferes with the nocturnal sleep rhythm (e.g., those who work night shifts). Previous history of chemotherapy. Diagnosis of metastasis. Development of severe toxicities that could not be controlled with standard doses, such as nausea.
Age
From 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
A four-block randomization method will be used to assign participants to groups. To allocate 36 samples per group (72 total participants), 18 blocks of 4 are needed. To select the 18 blocks, 18 random numbers between 1 and 6 will be generated with replacement. Thus, a sequence of letters A and B, including 72 letters (36 A's and 36 B's), will be created. Based on the generated sequence, participants will be assigned to groups in order. The random numbers generated in the R software and the random block assigned to the generated numbers. For example, the first person who meets the inclusion criteria for the study will be placed in group B, the second person in group B, the third person in group A, and the fourth person in group A, and so on up to 72 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigator, healthcare personnel (doctors, nurses, etc.) responsible for patient care, data collectors, outcome assessors, and those who prepare the manuscript draft.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, Campus of Sabzevar University of Medical Sciences, after the shohada gomnam Memorial, shohada hasteyi Boulevard.
City
sabzevar
Province
Razavi Khorasan
Postal code
9175995957
Approval date
2025-03-08, 1403/12/18
Ethics committee reference number
IR.MEDSAB.REC.1403.182

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 FACIT-Fatigue
Timepoint
evaluation of the fatigue score one week before intervention, after chemotherapy and one month after the end of chemotherapy
Method of measurement
FACIT-Fatigue quastionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: will receive 5 mg of melatonin produced by Tehran Darou Pharmaceutical Company daily from one week before the start of chemotherapy to one month after the end of it
Category
Treatment - Drugs

2

Description
Control group: will receive placebo daily from one week before the start of chemotherapy to one month after the end of it
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
seyed alireza javadinia
Street address
Vasei hospital., Shohaday Hasteyi Blvd., Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9175995957
Phone
+98 51 4465 1300
Email
vasei.h@medsab.ac.ir

2

Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Sareh Hosseini
Street address
Omid hospital., Koohsangi Blvd., Mashhad,
City
mashhad
Province
Razavi Khorasan
Postal code
9175995957
Phone
+98 51 3842 6082
Email
omidhos@mums.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Danial Fazilat Panah
Street address
Shahid Rajaee Hospital., Shariati St., Babolsar
City
Babolsar
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3528 9260
Email
nfo@mubabol.ac.ir

4

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Alireza Keramati
Street address
Sheykh Bahayi st., Molla Sadra St., Vanak Square., Tehran
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 21 8805 0435
Email
info@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Alireza Javadi Nia
Street address
Research and Technology Department., Medical University Campus., after Shohada Gomnam Memorial., Shohada hasteyi Blvd., Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8383
Email
CMRC@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Shervin Mashreghi moghaddam
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175995957
Phone
+98 51 3843 9335
Fax
Email
bdmashreghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shervin Mashreghi moghaddam
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175995957
Phone
+98 51 3843 9335
Fax
Email
bdmashreghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shervin Mashreghi moghaddam
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175995957
Phone
+98 51 3843 9335
Fax
Email
bdmashreghi@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
All potential data is shareable after de-identifying individuals
When the data will become available and for how long
Access period begins after results are published
To whom data/document is available
Our data will only be accessible to researchers employed in academic and scientific institutions
Under which criteria data/document could be used
To conduct other similar academic and scientific studies
From where data/document is obtainable
Via Shervin Mashreghi Moghaddam's email bdmashreghi@gmail.com
What processes are involved for a request to access data/document
The applicant must provide documentation of their academic and university position, the title of the study, and the type of data usage
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