Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lady Davis Institute | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| onabotulinumtoxinA | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | Injection of onabotulinumtoxinA into the at-risk major salivary glands |
|
| Measure | Description | Time Frame |
|---|---|---|
| Xerostomia-related quality of life | University of Washington Quality of Life questionnaire (higher score is better) | Pretreatment, 6 and 12 months from treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pretreatment and 12 months from treatment completion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University | Montreal | Quebec | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Injection of normal saline into the at-risk major salivary glands |
|
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |