Protocol summary
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Study aim
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Determination of Zataria Multiflora essential oil effect on protection of salivary glands from radiation damage in thyroid cancer patients referred to nuclear medicine ward of Namazi hospital for radioactive iodine therapy in a randomized double-blinded, placebo controlled, clinical trial
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Design
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Double blinded randomized placebo controlled clinical trial, with parallel groups, phase 3, designed of 88 patients, randomized with rand function of the Excel software
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Settings and conduct
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Subjects will be randomly divided into 2 groups: A and B, using block randomization method. One is the intervention group and the other is the control group. The intervention and control groups will receive 20 drops of 2% essential oil of Zataria multiflora or placebo three times a day respectively from 1 week before the radioactive iodine therapy to 4 weeks after that. Salivary gland scans will be performed before receiving radioiodine and 6 months after that. The duration of the intervention will be 5 weeks. Before starting the study, patients will be divided into two groups of 44 people based on a checklist by block randomization method. Drug and placebo are labeled as A and B. Patients of group A will receive drug A and patients in group B will receive drug B. Study at the patient level, outcome evaluator and statistical analyzer of the results will be blinded.
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Participants/Inclusion and exclusion criteria
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Patients affected with thyroid cancer who are candidates for radio-iodine therapy
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Intervention groups
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Patients will be allocated in two groups and will receive Zataria Multiflura essential oil or placebo from one week before radioiodine therapy till four weeks after that.
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Main outcome variables
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Prevention of salivary glands' radiation damage
General information
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Reason for update
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Due to the covid 19 pandemia and the significant reduction of patients in the department and the failure of nuclear medicine devices, the date of patient recruitment and the sample size is changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140514017684N8
Registration date:
2020-11-12, 1399/08/22
Registration timing:
prospective
Last update:
2022-09-08, 1401/06/17
Update count:
1
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Registration date
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2020-11-12, 1399/08/22
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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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2020-11-15, 1399/08/25
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Expected recruitment end date
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2021-09-16, 1400/06/25
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Actual recruitment start date
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2020-12-01, 1399/09/11
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Actual recruitment end date
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2021-09-16, 1400/06/25
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Trial completion date
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2022-03-16, 1400/12/25
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Scientific title
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Assessment of Zataria Multiflora essential oil on protection of salivary glands from radiation damage in differentiated thyroid cancer patients in a randomized double-blinded, placebo controlled, clinical trial
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Public title
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The effect of Zataria Multiflora on protection of salivary glands from radiation damage
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients affected with thyroid cancer who are candidates for radio-iodine therapy
Exclusion criteria:
Patients whose ages are less than 18
Patients who are affected with diseases affecting salivary glands such as Sjogren
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
88
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
4
2 parotid salivary glands and 2 submandibular salivary glands
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation, blocking, using the "rand" function of excel program, allocated as A and B
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Drug and placebo will be labeled as A and B by the drug producer. Patients allocated in group A and B will receive drug A and B respectively. Patients and chief researcher would not be aware of the coding.
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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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2020-06-15, 1399/03/26
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.244
Health conditions studied
1
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Description of health condition studied
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Salivary glands' damage
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Ejection fraction of Parotid glands
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Timepoint
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Before radioactive iodine therapy and 6 months after that
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Method of measurement
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Salivary gland scintigraphy
Intervention groups
1
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Description
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Intervention group: Patients will receive 20 drops of 2% solution of Zataria multiflora essential oil, commercially available as Gastrolith made by Barij Essential company from 1 week before receiving radioactive iodine to 4 weeks after that.
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Category
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Prevention
2
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Description
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Control group: Patients will receive 20 drops of placebo solution containing the basic solution of Gastrolith, three times a day from 1 week before receiving radioiodine to 4 weeks after that.
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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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Shiraz 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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is 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
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Title and more details about the data/document
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Information about the main outcome will be shared.
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When the data will become available and for how long
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After the article is published, it will be possible to access the data for one year.
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To whom data/document is available
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Researchers working in academic and scientific institutions are allowed to use data.
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Under which criteria data/document could be used
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Research use of the data will be allowed.
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From where data/document is obtainable
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Applicants for the data can send their request to the following e-mail.
afsharm@sums.ac.ir
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What processes are involved for a request to access data/document
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Applicants must send their application to the e-mail address of the project manager. The requested data and documents will be sent to them within a maximum of one month.
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Comments
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