Skip to content

Administration of botulinum toxin in reserving the function of salivary gland in neck radiotherapy

Investigating the role of injection of botulinum toxin in reserving the function of salivary gland in patients treated with neck radiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180225038862N1
Enrollment
30
Registered
2019-03-09
Start date
2017-10-07
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Malignant tumors of head and neck. Malignant neoplasm of head, face and neck

Interventions

Intervention 1: Intervention group: patients will be injected by 50 units botulinum toxin in submandibular gland before neck radiotherapy. Intervention 2: Control group: patients will be irradiated wi

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age older than 18 years

Exclusion criteria

Exclusion criteria: History of xerostomia History of previous neck radiotherapy History of collagen vascular disease

Design outcomes

Primary

MeasureTime frame
Xerostomia. Timepoint: Xerostomia will be evaluated before starting radiotherapy and 6 months after finishing radiotherapy. Method of measurement: Xerostomia will be evaluated through scintigraphy of sub-mandibular gland.

Secondary

MeasureTime frame
Constipation. Timepoint: Constipation will be evaluated before injection of toxin and 6 months after injection. Method of measurement: Constipation will be evaluated through history.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Farshid Farhan

Tehran University of Medical Sciences

farhan@tums.ac.ir+98 21 6119 2536

Outcome results

None listed

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