Clinical trial · Interventional
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head Neck Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Xerostomia Following Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OnabotulinumtoxinA | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The treating physician will perform the injection of normal saline under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of normal saline will be infiltrated the major salivary glands at-risk.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- onabotulinumtoxinA
- description
- The treating physician will perform the injection of onabotulinumtoxinA under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of onabotulinumtoxinA will be infiltrated the major salivary glands at-risk.
- interventionNames
- Drug: OnabotulinumtoxinA
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy). Exclusion Criteria: * Previous radiation to the head and neck * Previous treatment for head and neck cancer * Personal history of xerostomia * Hypersensitivity to onabotulinumtoxinA * Previous major salivary gland surgery * Previous exposure to radioactive iodine therapy
References
Publications (0)
Data not yet available