The study of the effect of chewing sugar-free gums after recieving I-131, on I-131 absorbed dose and its side effects in the salivary glands of patients with differentiated thyroid cancer
(1) I-131 administeration is one of the Known treatments which is used after thyroidecytomy in differentiated thyroid cancer patients. In spite of the fact that this is effective in destroying tumor tissue remnant, it has many side effects. One of them is transient or permanent damage and inflammation of salivary glands.
(2) This study evaluates the effect of chewing sugar-free gums , after administering radioactive Iodine, absorbed dose and incidence of side effects in salivary glands of thyroid cancer patients.
(3,4)60 patients will be chosen randomly among the patients who are administered radioactive iodine in nuclear medicine department at Shiraz Namazi hospital. They shouldn't have any positive history of previous salivary gland diseases, phenylketonuria, collagen tissue diseases and head and neck radiotherapy. They will divided into two intervention and one control groups.
(5)The two intervention groups will start chewing sugar-free gums, one from the first day after hospitalization and the other from the second day. All groups will have scintigraphy at 2, 5, 13, 24 and 48 hours after administering I-131. Also incidence rate of Sialadenitis and Xerostomia will be evaluated monthly from a weak after hospitalization up to 6 months.
(6)Finally we will evaluate the effect of chewing sugar-free gums after receiving radioactive iodine, on its absorbed dose and side effects in salivary glands of patients with differentiated thyroid cancer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062117684N5
Registration date:2014-11-10, 1393/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-10, 1393/08/19
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
2014-10-23, 1393/08/01
Expected recruitment end date
2015-06-19, 1394/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of chewing sugar-free gums after recieving I-131, on I-131 absorbed dose and its side effects in the salivary glands of patients with differentiated thyroid cancer
Public title
Evaluating the effect of chewing sugar-free gums after recieving I-131, on absorbed dose in the salivary glands.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
1- Patients older than 20 years for whom thyroidectomy has been performed for 4-6 weeks prior to initiation of the study due to differenciated thyroid cancer and are referred to Namazi Hospital Center of Nuclear Medicine for ablative radioactive iodine -131 therapy; 2- Patients who have received low-iodine diet for two weeks;
3- Patients must be at hypothyroid state at the time of the study;
4- Patients should have signed the informed consent form and should give permission for their participation in the study;
Exclusion Criteria:
1- Any positive history of previous salivary gland diseases;
2- Any positive history of collagen tissue diseases;
3- Positive history of Phenylketonuria;
4- Positive history of using diuretics, Antihistamines, Antidepressants or Anticholinergic medications;
5- Positive history of previously receiving Radiotherapy at Head & Neck region;
6- Positive history of previous treatment with radioiodine ( 131I );
7- Difficulty in taking large amount of fluid;
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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-9368-6618
Health conditions studied
1
Description of health condition studied
Thyroid cancer therapy with I-131
ICD-10 code
C73-C75
ICD-10 code description
Malignant neoplasms of thyroid and other endocrine glands
Primary outcomes
1
Description
Radioiodine absorbed dose
Timepoint
5 time points : At 2, 5, 13, 24 & 48 hours after receiving Radioiodine
Method of measurement
Radioiodine absorbed dose will be measured by scintigraphy and the amounts measured will be interpreted by MIRD Schema software.
Secondary outcomes
1
Description
Incidence rate of Sialadenitis and Xerostomia in under study patients
Timepoint
Attime points: 1 week after initial admission period then monthly follow ups till 6 months
Method of measurement
By making phone calls at chosen time points and collecting subjective data about patients’ symptoms
Intervention groups
1
Description
Intervention group(1): using sugar-free chewing gum from the first day of treatment.
Category
Prevention
2
Description
Intervention group(2): using sugar-free chewing gum from the second day of treatment
Category
Prevention
3
Description
Control Group: Do not use chewing gum
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)