At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 91 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2019-05-01
- Last checked
- 2024-05
Plain English Summary
What is this study?
- • Testing a new treatment for head and neck neoplasms
- • Clinical study - 100 participants
- • Radiotherapy and combined radiotherapy and chemotherapy are used to treat most tumours in the head and neck region
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with head and neck neoplasms
Where?
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Radiotherapy and combined radiotherapy and chemotherapy are used to treat most tumours in the head and neck region. Unfortunately, these treatments often result in hearing loss and tinnitus that has a negative impact on quality of life. This study will use a battery of sensitive tests, including measures of hair cell and neural function, before and after treatment, to measure the effects of these treatments on auditory function. The results will be compared with the individual radiotherapy dose characteristics, using state-of-the-art data mining technology, to identify the auditory substructures that are most sensitive to radiation with respect to the effects on auditory function. The data will provide the basis for new dose constraints to limit radiation doses to any identified substructures and to minimise loss in hearing ability for patients undergoing treatment for head and neck cancer.
More detail
The overall aim is to provide the data that will define radiotherapy dose constraints for individual substructures of the auditory pathway such that a better balance can be made between hearing loss and tumour control during radiotherapy for head and neck cancer. In particular the study aims to: 1. Determine the impact of radiotherapy to the head and neck region on auditory function, including measures of hair cell and neural function 2. Determine the interaction between radiation and cisplatin chemotherapy on auditory function 3. Determine relations between different functional effects and radiation dose to substructures within the ear using advanced voxel-based data mining techniques 4. Determine the auditory substructure that is most associated with speech-in-noise deficits 5. Identify and validate a test which is most predictive of damage to that substructure, and could be the basis for future diagnosis 6. Validate the importance of the localised sensitive substructure in an independent cohort
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Diagnosed with head and neck cancer
- ✓An MDT treatment decision of radiotherapy +/- cisplatin based drug treatment
Who cannot take part
- ✗Hearing loss greater than 25 dB HL (average from 0.25 to 4 kHz) prior to the study
- ✗Existing hearing loss (self-reported- need for hearing aid)
- ✗An MDT treatment decision of carboplatin based drug treatment
- ✗Involved in another research project where the treatment is known to be ototoxic
- ✗Unable to give agreement to take part
See the full criteria
Where Is This Study? (1 UK site)
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Chris Plack, PhD
Sponsor contactCONTACT