None listed
Conditions
Brief summary
This study is looking at the use of attenuated Botulinium Toxin to prevent long term loss of salivary secretion in patients undergoing radiation of the head & neck for malignancies. Botulinium Toxin is used to protect the parotid gland, responsible for 60% of resting saliva, from irradiation, and will be administered via a subcutaneous injection of the attenuated botulinum toxin delivered directly into the parotid gland through the skin. This will cause the gland to slow down, and therefore avoid becoming the target of irradiation. Xerostomia (or dry mouth) is a dehabilitating condition which is inevitable in bilateral neck irradiation for the treatment of head and neck cancers Trial Details In this study you will receive a single dose of attenuated botulinum toxin (100units), delivered via subcutaneous injection directly into the parotid gland through the skin 3-4 days prior to your scheduled radiation treatment. Who is it for? This study is available for participants 20 years and over who are undergoing radiation as the primary treatment modality, and have bilateral submandibular irradiation with existing head and neck cancer
Interventions
Single dose of attenuated botulinum toxin (100units), delivered directly via subcutanous injection into the parotid gland through the skin. 3-4 days prior to radiation treatment
Sponsors
Royal Darwin Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
>20 years old. Existing head and neck cancer. Radiation as the primary treatment modality. Bilateral submandibular irradiation
Exclusion criteria
No preexisting salivary gland disease
Outcome results
None listed