The value of intraglandular application of botulinum toxin for prevention of radiation-induced sialadenitis in head and neck cancer: a scintigraphic analysis.
- Conditions
- C15.9C33Oesophagus, unspecifiedMalignant neoplasm of trachea
- Registration Number
- DRKS00004595
- Lead Sponsor
- Koordinierungszentrum für Klinische Studien Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 13
Patients with a squamous cell carcinoma of the upper airways and oesophagus
Signed informed consent form
Cognitive and physical ability, to understand the aim of the trial and to adhere to the protocol
Age = 40 years
Gender: female and male participants
fertile woman over 40 years have to use one of the following contaceptive methods: the pill and contraceptive coil,
since at least to one month before study start
barrier with spermicide (condom or diaphragm), tube ligature. Fertile woman are defined as women whose last menstruation dates back no longer than one year
No functional restrictions and sides differences detected by scintigraphy of the salivary glands
condition after exstirpation of the salivary glands
known illnesses of the salivary glands
Concomitant medication, which affect the salivary glands
condition after previous radiotherapy of cervical soft tissue
pregnancy, lactation, Irenat-Therapy,
hypersensitivity to Botulinum toxin or one of the other components
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of the proportional uptake of radionuklide after treatment with BoNT or placebo. The primary endpoint will be determined via szinitgraphiy before and after study treatment.
- Secondary Outcome Measures
Name Time Method difference of the ejection fractions of the salviary glands either treated withe BoNT or placebo after administration of an irritant drink