Can we use ultrasound to assess the structure and size of important speech and swallowing muscles before and after radiotherapy ?
| ISRCTN | ISRCTN14681287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14681287 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 342478 |
| Protocol serial number | EDGE 173802 |
| Sponsor | Imperial College Healthcare NHS Trust |
| Funders | Imperial College London, National Institute for Health and Care Research |
- Submission date
- 03/03/2025
- Registration date
- 06/03/2025
- Last edited
- 06/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Radiotherapy is regularly used to cure and treat head and neck cancer. It can lead to changes in the structure and function of important muscles used in speech and swallowing, such as those in the tongue, neck, and jaw. Changes start during radiotherapy and can become worse over time, even after treatment finishes. We do not understand exactly when or how these changes happen, or how to treat them. Patients tell us side effects of radiotherapy can be very difficult to live with. This research aims to establish if ultrasound will be helpful in assessing the size and structure of the muscles involved in speech and swallowing in head and neck cancer patients before and after radiotherapy treatment.
The outcomes will be:
1. Assess whether ultrasound is helpful for assessing speech and swallowing muscles in head and neck cancer.
2. Find out if participants find ultrasound an acceptable assessment
3. Compare ultrasound findings of the 20 head and neck cancer patients with patient reported outcomes.
4. Complete engagement activities with patients and the public about their thoughts regarding ultrasound to guide the research. This will include focus group discussions, interviews and trying out ultrasound equipment.
Who can participate?
This will be a small pilot study of approximately 20 patients.
Patients will have a diagnosis of squamous cell cancer of the head and neck area.
Their treatment will be radiotherapy or chemotherapy plus radiotherapy with the aim of curing their cancer
What does the study involve?
The study involves the participants having an ultrasound before they start radiotherapy, and between 3-6 months after they have finished. They will also fill out two questionnaires about their swallowing and speech symptoms, and another questionnaire about the ultrasound. This will help understand if ultrasound is acceptable to participants.
What are the possible benefits and risks of participating?
There are no direct benefits to participants. There are no risks to participants although the ultrasound is extra time spent in clinic.
The expected benefits of the overall research are:
1. Improved understanding of the effects of radiotherapy on the structure and possible link to for function of speech and swallowing muscles in head and neck cancer patients
2. Potential for early identification of muscle changes using ultrasound imaging. This will enable targeted rehabilitation exercises for patients that may slow down any deterioration in how the muscles are working.
3. Understanding what patients and the public think about the introduction of ultrasound as part of their treatment.
Where is the study run from?
The study is run from Charing Cross Hospital (UK)
When is the study starting and how long will it run for?
September 2024 to December 2025
Who is funding the study:
Imperial College London Seedfund Grant, and an NIHR Senior Clinical and Practitioner Research Award (UK)
Who is the main contact?
Dr Gemma Clunie, gemmaclunie@nhs.net
Contact information
Public, Scientific, Principal investigator
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
 ORCID ID |
0000-0002-1796-731X |
|---|---|
| Phone | +44 7764678861 |
| gemmaclunie@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Feasibility reliability and acceptability study to use an ultrasound assessment protocol in clinical practice with a head and neck cancer population with an embedded pilot observational study |
| Secondary study design | Case series |
| Participant information sheet | 46934 QMUS-HNC-RT PIS_Version1.3 5.11.2024 final.pdf |
| Scientific title | An investigation of the feasibility, reliability and acceptability of using of ultrasound to assess muscle echogenicity and size in key speech and swallowing tissues before and after radiotherapy in a head and neck cancer population |
| Study acronym | QMUS-HNC-RT |
| Study objectives | It is feasible, reliable, and acceptable to use ultrasound assessment to assess muscle echogenicity and size in a pre- and post-radiotherapy head and neck cancer population. |
| Ethics approval(s) |
Approved 02/12/2024, West Midlands - Solihull (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 207 104 8124; solihull.rec@hra.nhs.uk), ref: 24/WM/0224 |
| Health condition(s) or problem(s) studied | Squamous cell carcinoma of tongue, tongue base, tonsil, oropharynx, hypopharynx or larynx, radical radiotherapy or chemoradiotherapy as primary curative treatment plan. |
| Intervention | Participants will fill in questionnaires and have ultrasound assessment at baseline and between 3 and 6 months post treatment. Participants will be enrolled in the study for approximately 6 months, depending on the timing of the post-treatment ultrasound scan which will be arranged at a convenient date and time to the participant. |
| Intervention type | Other |
| Primary outcome measure(s) |
Feasibility outcome measures: |
| Key secondary outcome measure(s) |
1. Ultrasound data will be collected prior to radiotherapy (baseline), and following radiotherapy (at least 3 months post) - the images will be used to assess the parameters described below: |
| Completion date | 06/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Over 18 years 2. Diagnosis of squamous cell carcinoma of tongue, tongue base, tonsil, oropharynx, hypopharynx or larynx 3. Radical radiotherapy/chemoradiotherapy as primary curative treatment plan 4. Able to give written consent |
| Key exclusion criteria | 1. Under 18 years 2. Other primary carcinoma site 3. Surgery as primary treatment plan 4. Unable to give written consent 5. Unable to complete patient reported outcome measures due to cognitive impairment |
| Date of first enrolment | 07/03/2025 |
| Date of final enrolment | 06/12/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Fulham Palace Road
London
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be available upon request from Dr Gemma Clunie gemmaclunie@nhs.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 05/11/2024 | 06/03/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.4 | 26/11/2024 | 06/03/2025 | No | No |
Additional files
- 46934 QMUS-HNC-RT Protocol V1.4 26.11.2024_.pdf
- Protocol file
- 46934 QMUS-HNC-RT PIS_Version1.3 5.11.2024 final.pdf
- Participant information sheet
Editorial Notes
04/03/2025: Trial's existence confirmed by NHS HRA.
