Prophylactic swallowing exercise program in head and neck cancer patients
| ISRCTN | ISRCTN98243550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98243550 |
| Secondary identifying numbers | B300201835273 - protocol version 2 |
- 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
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
Scientific
Wilrijkstraat 10
Edegem
2650
Belgium
| Phone | +3238213441 |
|---|---|
| gwen.vannuffelen@uza.be |
Public
Wilrijkstraat 10
Edegem
2650
Belgium
| Phone | +3238213441 |
|---|---|
| gwen.vannuffelen@uza.be |
Study information
| Study design | Interventional multi-centre three-armed randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2017 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Belgium
Belgium
Belgium
Belgium
Belgium
Netherlands
Sponsor information
Hospital/treatment centre
Wilrijkstraat 10
Edegem
2650
Belgium
| Phone | +3238213441 |
|---|---|
| gwen.vannuffelen@uza.be | |
"ROR" |
https://ror.org/01hwamj44 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 15/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/03/2020 | 04/03/2020 | Yes | No |
| 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 |
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.
