(1)Radioiodine therapy is used for thyroid cancer patients who are underwent total thyroidectomy. After administering radioiodine, Patients should be hospitalized in a controlled area for about 48 hours in order that the measured ambient equivalent dose from the gamma rays which emit from their total body reduces to a standard level.
(2)As some of the administered radioiodine is excreted by perspiration and since patients have enough free time during the hospitalization, (3) so we seek whether a specific exercise program can affect the equivalent dose in patients which are able to run (on treadmill).
(4) This study is being conducted for patients with differentiated thyroid cancer without metastasis who are underwent total thyroidectomy and treated with radioiodine. 30 person choose as a pilot study among patients who do not have renal failure, do not administering diuretics and are able to exercise. Patients will be divided into two control and intervention groups.
(5)Intervention group walk on treadmills for four, twenty minutes, intervals during hospitalization and the control group don't have any specific activity at these times. Immediately after each exercise process, both groups take shower and also their equivalent dose are measured before and after each process.
(6) At the end, by computing variation levels of dose in each group, we will evaluate the effect of exercise on equivalent dose of gamma rays that are emitted from thyroid cancer patients body.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060817684N2
Registration date:2014-10-29, 1393/08/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-29, 1393/08/07
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
2014-11-01, 1393/08/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of exercise on equivalent dose of gamma ray in patients treated by I-131 in Namazi hospital of shiraz, Iran
Public title
The effect of exercise on radioactive Iodine exclusion from body
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with differentiated thyroid cancer underwent total thyroidectomy and treated with radioiodine
Exclusion criteria: metastasis; renal failure; administering diuretics and unable to exercise.
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)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
2014-05-20, 1393/02/30
Ethics committee reference number
CT-P-9365-6635
Health conditions studied
1
Description of health condition studied
Thyroid Cancer therapy with I-131
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ambient equivalent dose
Timepoint
6, 24 and 48 hours after administering radioiodine
Method of measurement
Environmental dosimeter
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Having excercise test for 4 times in 48 hours after administering I-131
Category
Prevention
2
Description
control group: Do not have any exercise terst.
Category
N/A
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
11351-71937
Phone
+98 71 1612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)