None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of a new approach to radiation therapy to the head and neck region at reducing the incidence of dry mouth toxicity. Who is it for? You may be eligible for this study if you are undergoing radical or high dose palliative intent primary radiation therapy with or without chemotherapy for primary carcinoma of the head and neck region with an intention to spare one or more major salivary glands. Study details An MRI scan will be used to plan an avoidance region within the parotid gland to be spared during radiation therapy. Participants will be asked to complete surveys assessing dry mouth toxicity and quality of life up to 5 years post-completion of radiation treatment. It is hoped that findings from this study will help inform dose optimisation of radiation therapy to the head and neck to address dry mouth, which still remains one of the most debilitating side effects of radiation in head and neck cancer patients.
Interventions
A biological at-risk volume (BRV) within the parotid gland will be generated using the apparent diffusion coefficient map from the diffusion weighted magnetic resonance imaging (MRI) scan. This volume will be avoided during radiotherapy dose optimisation for head and neck cancer. This intervention will be completed across multiple disciplines, The radiation oncologist and radiation therapist will generate the BRV during the radiotherapy planning stages, the radiation therapist will complete the
A biological at-risk volume (BRV) within the parotid gland will be generated using the apparent diffusion coefficient map from the diffusion weighted magnetic resonance imaging (MRI) scan. This volume will be avoided during radiotherapy dose optimisation for head and neck cancer. This intervention will be completed across multiple disciplines, The radiation oncologist and radiation therapist will generate the BRV during the radiotherapy planning stages, the radiation therapist will complete the dose optimisation, the radiation oncologist will approve the plan, medical physicist will perform patient specific quality assurance and the radiation therapists will administer the treatment. Daily cone beam computed tomography imaging will be performed prior to treatment where an evaluation will be made on any patient separation changes, however the primary tumour will be prioritised during imaging. Common Terminology Criteria for Adverse Events and patient quality of life questionnaires will be completed at specific time points to monitor outcomes.
Sponsors
Sunshine Coast University Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed primary carcinoma of the head and neck region with an intention to spare one or more major salivary glands - Suitable for magnetic resonance imaging (MRI) Simulation - Aged 18 years or older - Have the ability to provide informed consent - Undergoing radical or high dose palliative intent primary radiation therapy +/- chemotherapy to a minimum prescription of 50Gy in 20 fractions (number of treatments)
Exclusion criteria
- Previous radiation therapy to major salivary glands - Pre-existing loss of salivary function eg. Previous salivary condition - Pregnancy - Recruitment to another clinical trial - Contraindication to MRI (Significant claustrophobia, pacemaker/defibrillator or other active implanted devices or implanted metals or foreign bodies)
Outcome results
None listed