Can we use ultrasound to assess the structure and size of important speech and swallowing muscles before and after radiotherapy ?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14681287

Enrollment

Registered

2025-03-06

Start date

2025-03-07

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of tongue, tongue base, tonsil, oropharynx, hypopharynx or larynx, radical radiotherapy or chemoradiotherapy as primary curative treatment plan. Cancer

Interventions

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, d

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Feasibility outcome measures: 1. Visibility of each muscle is measured using a three-point scale of visibility (clear, questionable, not visible) at baseline and between 3 and 6 months post treatment 2. Echogenicity is measured using greyscale analysis at baseline and between 3 and 6 months post treatment 3. Muscle thickness is measured using electronic callipers at baseline and between 3 and 6 months post treatment 4. Cross-sectional area is measured using continuous trace calipers at baseline and between 3 and 6 months post treatment 5. Inter-rater measurement reliability of thickness, cross-sectional area, and echogenicity is measured using intra-class correlation coefficient (ICC) at baseline and between 3 and 6 months post treatment 6. Intra-rater measurement reliability of thickness, cross-sectional area, and echogenicity is measured using Cronbach’s alpha at baseline and between 3 and 6 months post treatment 7. Acceptability of US to patients is measured using survey responses and a visual analogue scale at baseline and between 3 and 6 months post treatment	—

Measure

Time frame

Feasibility outcome measures: 1. Visibility of each muscle is measured using a three-point scale of visibility (clear, questionable, not visible) at baseline and between 3 and 6 months post treatment 2. Echogenicity is measured using greyscale analysis at baseline and between 3 and 6 months post treatment 3. Muscle thickness is measured using electronic callipers at baseline and between 3 and 6 months post treatment 4. Cross-sectional area is measured using continuous trace calipers at baseline and between 3 and 6 months post treatment 5. Inter-rater measurement reliability of thickness, cross-sectional area, and echogenicity is measured using intra-class correlation coefficient (ICC) at baseline and between 3 and 6 months post treatment 6. Intra-rater measurement reliability of thickness, cross-sectional area, and echogenicity is measured using Cronbach’s alpha at baseline and between 3 and 6 months post treatment 7. Acceptability of US to patients is measured using survey responses and a visual analogue scale at baseline and between 3 and 6 months post treatment

—

Secondary

Measure	Time frame
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: 1.1. Visibility data will be described using a three-point scale of visibility (clear, questionable, not visible) 1.2. Echogenicity (gray scale) of a defined region of interest for each muscle will be measured using specialist software, this will generate a numeric value between 0 and 255 1.3. Muscle thickness will be calculated by electronic callipers positioned at standard locations; cross-sectional area will be calculated using continuous trace calipers to outline the muscles of interest which will automatically generate a cross-sectional area. 2. Patient Reported Outcome Measures 2.1. Experience of swallowing symptoms measured using the MD Anderson Dysphagia Index (MDADI) at baseline and following radiotherapy (at least 3 months post) 2.2. Experience of speech symptoms Speech Handicap Index (SHI) measured at baseline and following radiotherapy (at least 3 months post) 3. Clinical Reported Outcome Measures 3.1. Clinician rating of swallowing and speech performance will be measured by the Performance Status Scale Head and Neck (PSS-H&N) at baseline and following radiotherapy (at least 3 months post) 3.2. Clinician rating of diet and fluid level and intake will be measured by the Functional Oral Intake Scale (FOIS) at baseline and following radiotherapy (at least 3 months post) 3.3. Clinican rating of diet and fluid description will be measured by the International Dysphagia Diet Standardisation Initiative (IDDSI) diet and fluids level at baseline and following radiotherapy (at least 3 months post) 4. Acceptability 4.1. An online questionnaire including visual analogue score (VAS) will be used to assess acceptability of the ultrasound at baseline and following radiotherapy.	—

Measure

Time frame

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: 1.1. Visibility data will be described using a three-point scale of visibility (clear, questionable, not visible) 1.2. Echogenicity (gray scale) of a defined region of interest for each muscle will be measured using specialist software, this will generate a numeric value between 0 and 255 1.3. Muscle thickness will be calculated by electronic callipers positioned at standard locations; cross-sectional area will be calculated using continuous trace calipers to outline the muscles of interest which will automatically generate a cross-sectional area. 2. Patient Reported Outcome Measures 2.1. Experience of swallowing symptoms measured using the MD Anderson Dysphagia Index (MDADI) at baseline and following radiotherapy (at least 3 months post) 2.2. Experience of speech symptoms Speech Handicap Index (SHI) measured at baseline and following radiotherapy (at least 3 months post) 3. Clinical Reported Outcome Measures 3.1. Clinician rating of swallowing and speech performance will be measured by the Performance Status Scale Head and Neck (PSS-H&N) at baseline and following radiotherapy (at least 3 months post) 3.2. Clinician rating of diet and fluid level and intake will be measured by the Functional Oral Intake Scale (FOIS) at baseline and following radiotherapy (at least 3 months post) 3.3. Clinican rating of diet and fluid description will be measured by the International Dysphagia Diet Standardisation Initiative (IDDSI) diet and fluids level at baseline and following radiotherapy (at least 3 months post) 4. Acceptability 4.1. An online questionnaire including visual analogue score (VAS) will be used to assess acceptability of the ultrasound at baseline and following radiotherapy.

—

Countries

England, United Kingdom

Contacts

Public ContactGemma Clunie

gemmaclunie@nhs.net+44 7764678861

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026