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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014062117684N5
Enrollment
60
Registered
2014-11-10
Start date
2014-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid cancer therapy with I-131. Malignant neoplasms of thyroid and other endocrine glands

Interventions

Intervention 1: Intervention group(1): using sugar-free chewing gum from the first day of treatment. Intervention 2: Intervention group(2): using sugar-free chewing gum from the second day of treatm
Prevention
Intervention group(1): using sugar-free chewing gum from the first day of treatment.
Intervention group(2): using sugar-free chewing gum from the second day of treatment
Control Group: Do not use chewing gum

Sponsors

Shiraz university of medical science, Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

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;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNuclear medicine and molecular imaging research center

Shiraz university of medical science

nmmirc@yahoo.com+98 71 1612 5330

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026