Protocol summary
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Study aim
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Determining the Effect of Melatonin Drug in Decresing Fatigue Caused by Adjuvant Radiation therapy and Chemotherapy in Breast Cancer Patients
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Design
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Phase 3 clinical trial with 64 patients with control group, community-based and pragmatic, with parallel groups, triple blinded, with a randomized block design
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Settings and conduct
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Female breast cancer patients with stages I to III who during the second half of 1397 will be referred to Mahdieh Hospital and Besat Hospital for receiving adjuvant radiation therapy and chemotherapy, using a simple randomization method, and with a full explanation of the study and Written consent will be entered into the study. with a randomized block design patients will be treated with melatonin or placebo( control group). For blinding medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes is done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, are not aware of the intervention type received, and Who is located in each group
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Participants/Inclusion and exclusion criteria
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Female breast cancer patients with stage I-III( according to the AJCC) who receive adjuvant chemotherapy and radiation therapy;
No Consumption of Warfarin, Methylphenidate and Hypnotics during using Melatonin, No Pregnancy or Breastfeeding
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Intervention groups
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Patients will be randomly treated with melatonin or placebo( control group). Oral Melatonin Drug 6 mg( 2 mg capsule 3 mg) from 3 to 7 days before the start of Adjuvant treatment will be consumed every night until the disease progression
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Main outcome variables
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Type of treatment;
Gender;
Age;
Fatigue severity;
The type of adjuvant treatment
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180426039421N1
Registration date:
2018-06-16, 1397/03/26
Registration timing:
prospective
Last update:
2018-09-11, 1397/06/20
Update count:
1
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Registration date
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2018-06-16, 1397/03/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-07, 1397/07/15
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Expected recruitment end date
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2019-03-21, 1398/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the Effect of Melatonin Drug in Decreasing Fatigue Caused by Adjuvant Radiotherapy and Chemotherapy in Women with Breast Cancer: A Clinical Trial
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Public title
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Effect of Melatonin Drug in Decreasing Fatigue Caused by Radiotherapy and Chemotherapy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Breast Cancer Stages I, II, III According to Pathological Reports
Patients at least 18 Years Old
Have Signed a Written Consent
Recevieng Adjuvant Chemotherapy and Radiotherapy
No Untreated Hypercalcemia
No Systolic Blood Pressure Less Than 100 mm Hg
No Warfarin Consumption
No Methylphenidate Consumption
No Sleep Pills During Melatonin Use
No TSH>5/5 or <0/5
No Pregnancy or Breastfeeding
Exclusion criteria:
Expired During Treatment
Stop Using Melatonin during Treatment
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Age
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From 18 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Any number of female breast cancer patients with stage I-III( according to the AJCC system) are selected by simple randomization method and the patients are randomized (randomized block design) to receive melatonin or placebo (control group) .
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Blinding includes:
Participants( patients)
Clinical care provider( radiotherapy-oncology physicians and chemotherapy nurses)
Researcher and evaluator of the outcome and data analyzer: (radiotherapy-oncology resident)
In order to hide allocation, medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes are performed by a non-involved person in data sampling and analysis. Thus, the clinical care provider, the data collector, the participant and the data analyst, are unaware of the type of intervention received and who is located in each group
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-21, 1397/02/01
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Ethics committee reference number
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IR.UMSHA.REC.1397.5
Health conditions studied
1
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Description of health condition studied
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Breast Cance; Cancer Related Fatigue; Melatonin
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
Primary outcomes
1
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Description
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Fatigue severity in the BFI questionnaire
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Timepoint
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4 weeks after last adjuvant treatment session
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Method of measurement
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Brief Fatigue Inventory( BFI) questionnaire
Intervention groups
1
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Description
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Intervention group: Oral Melatonin drug 6 mg( 2 capsule of 3 mg) every night from 3 to 7 days before the start of Adjuvant treatmentwill be used until the disease progresses
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Category
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Rehabilitation
2
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Description
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Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until the disease progresses
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available