Prophylactic swallowing exercise program in head and neck cancer patients

ISRCTN	ISRCTN98243550
DOI	https://doi.org/10.1186/ISRCTN98243550
Protocol serial number	B300201835273 - protocol version 2
Sponsor	Antwerp University Hopsital
Funder	Kom Op Tegen Kanker

Submission date: 08/11/2018
Registration date: 21/12/2018
Last edited: 09/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Swallowing problems (dysphagia) are a common and serious complication after (chemo)radiotherapy for head-and-neck cancer patients, preventative swallowing exercises have been studied widely and have shown a significant positive effect on post-treatment swallowing function. Unfortunately, low adherence rates are a key issue in undermining the positive effects of the exercises. This study aims to compare 3 types of swallowing exercise therapies to improve adherence.

Who can participate?
Adult patients with head-and-neck cancer treated with radiotherapy or chemoradiotherapy

What does the study involve?
Patients will be randomly allocated to one of three groups.
Patients allocated to Group 1 perform the exercises at home without supervision of a speech language therapist but with a counselling session of 10 minutes every week. Group 2 will practice the exercises at home and receive continuous counselling and instructions video via an app. Group 3 will receive face-to-face therapy and will be counselled by a speech language therapist five times a week. All patients will complete 20 sessions of exercises.

What are the possible benefits and risks of participating?
The possible benefit of participating is that recent research shows the positive effect of these swallowing exercises on swallowing function. There are no known risks to participants taking part in this study.

Where is the study run from?
Antwerp University Hospital and 4 hospitals in Belgium and 1 in the Netherlands

When is the study starting and how long is it expected to run for?
September 2017 to June 2022

Who is funding the study?
Kom Op Tegen Kanker (Belgium)

Who is the main contact?
Gwen Van Nuffelen
gwen.vannuffelen@uza.be

Contact information

Prof Gwen Van Nuffelen
Scientific

Wilrijkstraat 10
Edegem
2650
Belgium

Phone	+3238213441
Email	gwen.vannuffelen@uza.be

Prof Gwen Van Nuffelen
Public

Wilrijkstraat 10
Edegem
2650
Belgium

Phone	+3238213441
Email	gwen.vannuffelen@uza.be

Study information

Primary study design	Interventional
Study design	Interventional multi-centre three-armed randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Towards a patient supported, well tolerated and evidence based prophylactic swallowing exercise program to improve quality of life and swallowing function in head and neck cancer patients treated with chemoradiotherapy: a multicentre randomized controlled trial
Study acronym	PRESTO-trial
Study objectives	As patients’ adherence is a key issue regarding prophylactic swallowing exercises in head and neck cancer patients, this multicentric, randomized controlled trial aims to compare 3 therapy modes differing from each other in degree and type of adherence improving measures. Patients referred to group 1 or 2 will practice at home following an instruction session. Adherence is enhanced by means of weekly follow-up sessions (group 1 and 2) and by means of an app – developed for this particular purpose (group 2). The third group receives speech therapist supervised therapy. The degree of compliance, muscle strength, swallowing function and quality of life are the main outcome variables. The study design also allows to gain further insight in factors influencing compliance and to perform a cost-effectiveness study. The study hypotheses are therefore as follows: 1. Adherence will be larger in groups 2 and 3 compared to 1 2. A significant decrease of muscle strength, swallowing function and swallowing related quality of life is expected in every group 3. The higher the overall degree of adherence, the smaller the negative impact on muscle strength, swallowing function and swallowing related quality of life 4. The degree of adherence depends upon personality, intrinsic motivation, fatigue and pain in the oral cavity 5. The cost-effectiveness of group 2 is significantly higher compared to group 1 and 3
Ethics approval(s)	Antwerp University Hospital Belgium, 12/03/2018, B300201835273
Health condition(s) or problem(s) studied	Head and neck cancer treated with radiotherapy or concomitant chemoradiotherapy
Intervention	Participants will be randomly allocated to one of three groups using the Qminim program. All participants will complete prophylactic swallowing exercises during the first 4 weeks of treatment. Group 1 will complete the exercises at home and have a weekly follow-up session. Group 2 will complete the exercises at home and have support from an app, along with a weekly follow-up session. Group 3 will practice the exercises under the continuous supervision of a speech language pathologist. The exercises include tongue strengthening exercises, chin tucks against resistance and effortful swallows. Exercises will be perfomed 5 times per week, once per day, alternating tongue strength and chin tuck (chin tuck includes effortful swallows). Tongue strength exercises will involve 120 repetitions per day and chin tuck/effortful swallows will involve 150 reps per day. The total duration for all groups is 4 weeks. All participants will be followed weekly by a speech language therapist. After the radiotherapy treatment, all participants will be followed for 3 months - immediately after radiotherapy, after 1 month and after 3 months.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 15/02/2019: Swallowing function assessed , using the Mann Assessment of Swallowing Ability – Cancer (MASA-C) at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment Previous primary outcome measure: Degree of compliance, assessed weekly during the first 4 weeks of treatment, assessed using: 1. The total performed number of exercises per week, assessed by: 1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 2. Time spent on the app per day (for group 2 only), automatically registered
Key secondary outcome measure(s)	Current secondary outcome measures as of 15/02/2019: 1. Degree of compliance: assessed weekly during the first 4 weeks of treatment, using: 1.1. The total performed number of exercises per week, assessed by: 1.1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 1.2. Time spent on the app per day (for group 2 only), automatically registered 2. Swallowing function: assessed at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment, using: 2.1. Eating Assessment Tool (EAT-10) 2.2. Self-perception of swallowing ability, assessed using a visual analogue scale ranging from 0 ("I can’t swallow at all") to 100 ("I can swallow perfectly") 2.3. Functional Oral Intake Scale 50 (FOIS) 3. Tongue strength, assessed using the Iowa Oral Performance Instrument (IOPI) to measure the maximum isometric tongue pressure at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 4. Maximum muscle strength during Chin Tuck Against Resistance (CTAR), assessed using a dynamometer at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 5. Quality of life: assessed at the baseline, at the end of treatment, and 1 and 3 months after treatment using: 5.1. Swallowing Quality of Life Questionnaire (SWAL-QoL) 5.2. Dysphagia Handicap Index (DHI) 6. Cost-effectiveness analysis regarding adherence to prophylactic swallowing exercises, assessed using the EQ-5D-5L at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment Previous secondary outcome measures: 1. Swallowing function, assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using: 1.1. Mann Assessment of Swallowing Ability--Cancer score (MASA-C) 1.2. Eating Assessment Tool (EAT-10) 1.3. Self-perception of swallowing ability, assessed using a visual anlogue scale ranging from 0 ("I can’t swallow at all") to 100 ("I can swallow perfectly") 1.4. Functional Oral Intake Scale 50 (FOIS) 2. Tongue strength, assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using the Iowa Oral Performance Instrument (IOPI) to measure the maximum isometric tongue pressure 3. Maximum muscle strength during Chin Tuck Against Resistance (CTAR), assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using a dynamometer 4. Quality of life, assessed at the baseline, after 4 and 5 weeks, at the end of treatment, and 1 and 3 months after treatment using: 4.1. Swallowing Quality of Life Questionnaire (SWAL-QoL) 4.2. Dysphagia Handicap Index (DHI) 5. Cost-effectiveness analysis regarding adherence to prophylactic swallowing exercises, assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using the EQ-5D-5L
Completion date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Total final enrolment	150
Key inclusion criteria	1. Newly diagnosed squamous cell carcinoma of the oropharynx 2. Stage III or IV cancer (according to TNM-7 classification) 3. Treatment with radiotherapy or concomitant chemoradiotherapy with/without induction chemotherapy 4. Demonstrating sufficient cognitive and language abilities
Key exclusion criteria	1. Recurrent carcinoma or metastasis from a non-HNC (head and neck cancer) carcinoma 2. Previous radiotherapy and/or chemoradiotherapy ,or surgery in head-neck region with possible impact on swallowing function
Date of first enrolment	01/06/2018
Date of final enrolment	21/01/2022

Locations

Countries of recruitment

Belgium
Netherlands

Study participating centres

Antwerp University hopsital

2650
Belgium

University of Ghent

9000
Belgium

University Hospital Ghent

9000
Belgium

University Hospital Leuven

3000
Belgium

Az Sint Jan Brugge

8000
Belgium

Antoni Van Leeuwenhoek Ziekenhuis - Netherlands Cancer Institute

1066CX
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. All data will be stored in REDCap, a secure web application for building and managing online surveys and databases. (https://www.project-redcap.org/). Patient information (no identifying information), surveys and measurements will be shared. The data will be available for all participating study investigators until the end of the study. All data will be anonymised and patient’s details will be encoded.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		19/09/2022	20/09/2022	Yes	No
Results article	Effect of service-delivery mode and overall adherence level	08/08/2023	09/08/2023	Yes	No
Protocol article	protocol	02/03/2020	04/03/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/08/2023: Publication reference added.
20/09/2022: Publication reference added.
04/02/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 21/01/2022.
2. The total final enrolment was added.
13/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2021 to 28/02/2022.
2. The overall end date was changed from 31/12/2021 to 30/06/2022.
3. The intention to publish date was changed from 31/12/2021 to 15/10/2022.
4. The plain English summary was updated to reflect these changes.
04/03/2020: Publication reference added.
15/02/2019: The primary and secondary outcome measures were updated.
11/01/2019: Internal review.