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Evaluating the effect of chewing sugar-free gums after recieving I-131, on absorbed dose in the salivary glands.

Phase 2
Conditions
Thyroid cancer therapy with I-131.
Malignant neoplasms of thyroid and other endocrine glands
C73-C75
Registration Number
IRCT2014062117684N5
Lead Sponsor
Shiraz university of medical science, Vice chancellor for research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion 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;

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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