Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530524
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None