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Assessment of BoNT injection to protect against radioiodine induced sialadenitis

Assessment of BoNT injection to protect against radioiodine induced sialadenitis in patients with papillary thyroid cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230627058597N1
Enrollment
20
Registered
2024-09-23
Start date
2023-08-06
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Condition 1: sialadenitis. Condition 2: thyroid cancer. Sialoadenitis Carcinoma in situ of thyroid and other endocrine glands

Interventions

Intervention 1: Intervention group: In this group, the patient will be injected at most 100 units of Botox (Masport-Iran), once in bilateral parotid glands two weeks before radioiodine therapy. Interv

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: radioiodine candidates due to thyroid carcinoma accepted informed consent first time of radioiodine therapy over 18 years old

Exclusion criteria

Exclusion criteria: history of systemic diseases affecting saliva production history of medications affecting saliva production history of surgeries on salivary glands or salivary glands dysfunction history of botox allergies or contreindication

Design outcomes

Primary

MeasureTime frame
Saliva voloum. Timepoint: before and 6 month after radioiodine therapy. Method of measurement: saliva collection by stipping in a collection tube every 30 seconds for 5 minutes.;Salivary gland appearance and tenderness. Timepoint: before and 6 month after radioiodine therapy. Method of measurement: physical examination.;Painful saliva production during eatinf meals. Timepoint: before, 2 weeks and 6 month after radioiodine therapy. Method of measurement: history taking.;Score of "Summated xerostomia inventory-Dutch version" questionnaire. Timepoint: before, 2 weeks and 6 month after radioiodine therapy. Method of measurement: "Summated xerostomia inventory-Dutch version" questionnaire.

Secondary

MeasureTime frame
Laboratory and thyroid function tests. Timepoint: before and 6 month after radioiodine therapy. Method of measurement: laboratory assessments.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrshad Abbasi

Tehran University of Medical Sciences

meabbasi@tums.ac.ir00982161190

Outcome results

None listed

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