(1)Thyroid cancer patients who are treated with I-131 are quarantined in a controlled area according to Atomic Energy Organization guideline, so that the ambient equivalent dose in the specified distance from the patients becomes less than the permitted values. It is mentioned in the post treatment recommendations that excessive fluid usage can excrete radioactive from patient's body faster. So patients are recommended to drink liquid as much as possible.
(2)The purpose of this study is to evaluate the relationship between the amounts of used liquids and the delivered dose to body in patients treated with I-131.
(3) First, (4)30 patients will be chosen randomly as pilot study, among whom that are treated with I-131 in nuclear medicine department at Namazi Hospital of Shiraz. (5)These patients will be asked to drink different coefficients of their own maintenance fluid requirement. It is notable that maintenance fluid requirement for each person is calculated from their weight.
(6)Ambient equivalent dose of patients will be measured twice, once immediately after radioactive Iodine reception and the other one at 40 hours later.
At last we will try to find whether there is a significant relationship between total fluid intake and the ambient equivalent dose emitted from patients body.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051417684N1
Registration date:2014-08-01, 1393/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-01, 1393/05/10
Registrant information
Name
Mahdi Haghighatafshar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4835
Email address
afsharm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical science, Vice chancellor for research
Expected recruitment start date
2014-07-20, 1393/04/29
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the relation between the quantities of drank liquids and delivered dose to body of cancer thyroid patients treated with I-131
Public title
Drinking liquids in thyroid cancer therapy with I-131
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: thyroid cancer patients who treated with I-131 at nuclear medicine department in Namazi Hospital, shiraz, Iran.
Exclusion criteria: vomitting
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical science, Ethics Committee
Street address
Central building of Shiraz University of Medical Science, Karimkhan-e Zand Boulevard
City
shiraz
Postal code
14336 - 71348
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
CT-P-9362-6122
Health conditions studied
1
Description of health condition studied
Thyroid cancer
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Ambient equivalent dose
Timepoint
Before and after intervention
Method of measurement
Environmental dosimeter
Secondary outcomes
1
Description
Physiological characteristics of the patient
Timepoint
Before intervention
Method of measurement
Measurement and asking patient
Intervention groups
1
Description
Controlling quantities of drank liquids
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi Hospital
Full name of responsible person
Nuclear medicine and molecular imaging research center
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical science, Vice chancellor for research
Full name of responsible person
Zahra Pandkhahi
Street address
Central building of Shiraz University of Medical Science, Karimkhan-e Zand Boulevard
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical science, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Expert of the center
Other areas of specialty/work
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
11351-71937
Phone
+98 71 1612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Nuclear medicine Specialist
Other areas of specialty/work
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
71937-11351
Phone
+98 71 1612 5320
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)