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Evaluating the Effects of Melatonin Supplementation on Anxiety and Depression in Patients with Breast Cancer, a Randomized Clinical Trial Study

Protocol summary

Study aim
Determining the effects of melatonin supplementation on anxiety and depression in patients with breast cancer
Design
76 patients diagnosed with breast cancer and referred to Sabzevar Vasei Hospital will be enrolled in this study. Utilizing a random numbers table, patients will be allocated randomly into two groups: intervention and control, each comprising 38 participants. This study will be conducted as a controlled, parallel-group, double-blind, phase 2 randomized clinical trial.
Settings and conduct
76 patients with breast cancer who were referred to Vasi Sabzevar Hospital will be included in the study. The study will use the Beck's anxiety and depression questionnaires. The intervention group will take 3mg of melatonin daily before bedtime for a month, while the control group will receive a placebo. After a month, both groups will complete the questionnaire again and undergo an examination. Weekly visits will be conducted to check for adverse effects and anxiety-depression-related issues.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent Patients who have been treated for three months based on pathology results. People without diabetes, hypertension, cardiovascular diseases, kidney disease, liver disease, acute diseases, autoimmune disease, thyroid disorder, and mental disorders. Exclusion criteria: unwillingness to continue cooperating in the project, diagnosis of metastasis, and severe toxicities.
Intervention groups
For one month, 3 mg melatonin medicine is administered every night for the intervention group and a placebo with the same shape and color is prescribed for the control group.
Main outcome variables
Anxiety; Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240304061165N1
Registration date: 2024-07-13, 1403/04/23
Registration timing: prospective

Last update: 2024-07-13, 1403/04/23
Update count: 0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Vida Fazliani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 0965
Email address
fazlianimoghaddamv96@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Melatonin Supplementation on Anxiety and Depression in Patients with Breast Cancer, a Randomized Clinical Trial Study
Public title
Evaluating the Effects of Melatonin Supplementation on Anxiety and Depression in Patients with Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study. Patients with breast cancer under follow-up who have been treated for three months based on pathology results and were disease-free at the time of examination. People without diabetes, high blood pressure, cardiovascular diseases, kidney disease, liver disease, acute diseases, autoimmune disease, thyroid disorder, mental disorders
Exclusion criteria:
Patients with known underlying diseases including uncontrolled diabetes, uncontrolled high blood pressure, cardiovascular diseases, chronic kidney disease, chronic liver disease, autoimmune disease, thyroid disorder, and the use of uncontrolled psychiatric drugs. Unwillingness to continue cooperation in the project Diagnosis of metastasis Causing severe toxicities that could not be controlled with usual doses, such as nausea
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two intervention and control groups of 38 people. Randomization and allocation concealment will be done respectively from a random number table and sequentially numbered, sealed, opaque envelopes (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
While the patient is aware of the blinding of the study, both the patient and whether they receive the original drug or placebo are identified by a numerical or letter code. Thus, the participant, care provider, researcher, and outcome assessor, will not be aware of which individual or group received which drug (except in emergencies and according to the unblinding protocol).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Sabzevar, POBox 319, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.MEDSAB.REC.1402.125

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F43.22
ICD-10 code description
Adjustment disorder with anxiety

2

Description of health condition studied
Depression
ICD-10 code
F43.21
ICD-10 code description
Adjustment disorder with depressed mood

3

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

4

Description of health condition studied
Mixed Anxiety and Depression
ICD-10 code
F43.23
ICD-10 code description
Adjustment disorder with mixed anxiety and depressed mood

Primary outcomes

1

Description
Depression
Timepoint
Day 0 and 30 of intervention
Method of measurement
Beck's Depression Inventory (BDI)

2

Description
Anxiety
Timepoint
Day 0 and 30 of intervention
Method of measurement
Beck's Anxiety Inventory (BAI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will take a 3 mg melatonin tablet produced by Razak every night 0.5 to 1 hour before going to bed for 30 nights.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will take a placebo pill with the same shape and color every night 0.5 to 1 hour before going to bed for 30 nights.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Educational, Research and Treatment Center
Full name of responsible person
Pejman Porouhan
Street address
Vasei hospital , Shohadaye Hasteii Blvd , Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3861
Email
vc.Research@medsab.ac.ir
Web page address
https://www.medsab.ac.ir/index.aspx?siteid=1&pageid=158

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hassanpour
Street address
Vice-chancellor in Research and Technology, Sabzevar University of Medical Sciences, Sabzevar, POBox 319, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Fax
+98 51 4401 8484
Email
vc.Research@medsab.ac.ir
Web page address
https://www.medsab.ac.ir/index.aspx?siteid=1&siteid=1&fkeyid=&siteid=1&fkeyid=&siteid=1&pageid=2085
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
Sabzevar University of Medical Sciences
Full name of responsible person
Vida Fazliani Moghaddam
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 30, Moallem 22 Ave., Fazl Blv., Farhangian Town
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318786317
Phone
+98 51 4261 0965
Fax
Email
VidaFazliani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vida Fazliani Moghaddam
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 30, Moallem 22 Ave., Fazl Blv., Farhangian Town
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318786317
Phone
+98 51 4261 0965
Fax
Email
VidaFazliani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vida Fazliani Moghaddam
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 30, Moallem 22 Ave., Fazl Blv., Farhangian Town
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318786317
Phone
+98 51 4261 0965
Fax
Email
VidaFazliani@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
I have not decided yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The final clinical trial report, such as information about the main outcome, can be shared.
When the data will become available and for how long
The access starts 12 months after the results are published.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers must provide a detailed research proposal that aligns with the objectives of the original study and complies with ethical standards.
From where data/document is obtainable
Contact Vida Fazliani Moghaddam at +989158520600 (Telegram, WhatsApp) or via email at VidaFazilani@gmail.com or Vida.Fazlyani@gmail.com
What processes are involved for a request to access data/document
1. Initial Request: Submit a detailed research proposal and an Institutional Review Board (IRB) approval letter via email to Vida Fazilani. 2. Review Process: The Data Access Committee (DAC) and researchers will review the request within 5-8 weeks. 3. Approval and Agreement: Upon approval, sign the Data Use Agreement (DUA) within 2 weeks. 4. Data Access: Access credentials will be provided within 2 weeks of the DUA. Estimated Total Time: 10-13 weeks
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