A Phase 2 interventional study of OnabotulinumtoxinA and Placebo in Head Neck Cancer and Xerostomia Following Radiotherapy, sponsored by Sir Mortimer B. Davis - Jewish General Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Sir Mortimer B. Davis - Jewish General Hospital · Phase 2, Interventional, and Prevention
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 50 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Sir Mortimer B. Davis - Jewish General Hospital is the lead sponsor of 61 studies on the registry; 21 are open to participants now.
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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.
Drug: Placebo
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.
Drug: OnabotulinumtoxinA
Injection of onabotulinumtoxinA into the at-risk major salivary glands
Injection of normal saline into the at-risk major salivary glands
Xerostomia-related quality of life
University of Washington Quality of Life questionnaire (higher score is better)
Time frame: Pretreatment, 6 and 12 months from treatment completion
Unstimulated salivary function using salivary gland scintigraphy
Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy
Time frame: Pretreatment and 12 months from treatment completion
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Sir Mortimer B. Davis - Jewish General Hospital