None listed
Conditions
Brief summary
The aim of the present study is to compare normal tissue doses and toxicities between head and neck cancer patients with and without GrayDuck stent, who are treated with concurrent chemoradiation. The study hypothesis is that the stent application decreases both doses at organs at risk and treatment-related complications.
Interventions
GrayDuck stent is used during radiation treatment. The device is applied during CT simulation and throughout treatment delivery immediately before each session by radiation therapist. During fitting the GrayDuck stent requires a bite opening of at least 2 cm between top and bottom front teeth. Then, insert the depressing paddle into central anterior port of the arch tray. All the treatments are delivered in radiotherapy unit, Vajira Hospital, Bangkok, Thailand. To assess or monitor adherence or
GrayDuck stent is used during radiation treatment. The device is applied during CT simulation and throughout treatment delivery immediately before each session by radiation therapist. During fitting the GrayDuck stent requires a bite opening of at least 2 cm between top and bottom front teeth. Then, insert the depressing paddle into central anterior port of the arch tray. All the treatments are delivered in radiotherapy unit, Vajira Hospital, Bangkok, Thailand. To assess or monitor adherence or fidelity to the intervention, audit of medical records by principal investigator and/or secondary investigator is done. If there is any protocol deviation, the issue will be discussed and informed to the subject(s) involved in order to maintain or improve fidelity.
Sponsors
CQ Medical
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
nonmetastatic head and neck cancer with ECOG 0-2 receiving definitive concurrent chemoradiation via volumetric modulated arc therapy with dose of 70Gy in 33 fractions
Exclusion criteria
-Metastatic disease -Unable to receive concurrent chemoradiation
Outcome results
None listed