Prophylactic swallowing exercise protocol in head and neck cancer patients: combination of self-directed and supervised training
| ISRCTN | ISRCTN11188227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11188227 |
| Project ID number | 13359 |
| Sponsor | Antwerp University Hospital |
| Funder | Kom op tegen Kanker |
- Submission date
- 29/12/2025
- Registration date
- 26/02/2026
- Last edited
- 26/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims:
Head and neck cancer (HNC) is a highly prevalent disease on a global scale. In 2022, 2721 new cases were registered in Belgium. Organ-sparing treatments, such as concomitant chemoradiotherapy (CCRT) and radiotherapy (RT), are the standard of care for patients with primary HNC. Despite improvements in these treatments, dysphagia (swallowing problems) remains a prevalent and frequently reported complication following CCRT/RT. Over 50% of HNC patients experience radiation-associated dysphagia (RAD). The consequences of RAD can be severe, including a significantly reduced quality of life, malnutrition, dehydration and aspiration pneumonia. Consequently, it contributes significantly to non-cancer-related deaths in this population. Preventing this common side effect is essential to enhance quality of life (QoL) and extend long-term survival, while limiting the burden on healthcare resources. The growing number of human papillomavirus (HPV)-related oropharyngeal cancer patients and survivors makes prevention paramount.
Recently, further evidence has emerged regarding the beneficial effects of prophylactic swallowing exercises (PSE) on muscle condition, swallowing function and QoL in HNC patients undergoing (chemo)radiotherapy. Unfortunately, these positive effects are undermined by low (13%) to moderate (71%) adherence rates.
Being adherent to PSE during CCRT/RT is crucial. Adherence can be improved through continuous supervision, feedback after successful exercise performance and a close relationship between patients and therapists. The preceding multicentre randomized controlled KOTK-PRESTO trial focused on improving patients’ adherence to PSE. Patients were divided into three groups: diary-supported PSE (paper group), app-supported PSE (app group) and therapist-supported PSE (therapist group). These groups differed in the type and extent of adherence-improving measures. All patients received the same PSE program five times a week during the first 4 weeks of CCRT/RT. Patients in the PRESTO-therapist group (PRESTO-T) received face-to-face therapy with a speech and language pathologist (SLP). The PRESTO-paper group and PRESTO-app group performed the first exercise session under the supervision of the SLP. Patients recorded their exercises in a logbook or app. The participants in this study demonstrated higher overall adherence rates in comparison to those achieved in previous studies. A significant positive effect on swallowing function and muscle strength has been observed in patients who performed ≥75% of the exercises. This overall adherence (OA) rate was exclusively attained in the PRESTO-T group. The PRESTO-paper group approached this cut-off level with an overall adherence of 69%.
Despite the high rates of adherence to these treatments, face-to-face therapy can be burdensome for the patients. This approach requires more appointments and time spent in the hospital, in addition to all the other medical obligations. Furthermore, face-to-face therapy requires substantial human resources and poses considerable logistical challenges. A hybrid solution, combining face-to-face therapy with home practice, has the potential to optimize successful clinical implementation, making the effective PRESTO-program accessible to all HNC patients treated with CCRT/RT.
Who can participate?
Patients aged 18 years or older with head and neck cancer treated with radiotherapy or chemoradiotherapy.
What does the study involve?
Patients will be randomly allocated to one of two treatment groups. Participants in the PRESTO therapist group (PRESTO-T) will receive supervised, face-to-face therapy with a speech language pathologist (SLP) five times a week. The PRESTO hybrid group (PRESTO-H) will perform 50% of the prescribed prophylactic swallowing exercises at home and 50% under direct supervision of an SLP. The proportion of face-to-face contact will increase during the final week of training. Several measures were taken to facilitate adherence. For example, an e-health platform will provide reminders. In addition, with the patient's consent, caregivers will be actively involved. They will receive specific information on how to support the patient and will also be encouraged to attend the treatment sessions. Patients will receive a brochure and access to online information, including videos, and an information session before or during the first week of radiotherapy. The aim is for all patients to complete the 20 exercise sessions.
What are the possible benefits and risks of participating?
A key benefit is evidenced by the findings from the preceding PRESTO trial, which demonstrated a positive effect of prophylactic swallowing exercises on both swallowing function and muscle strength. There are no risks or side effects associated with participating in the study.
Where is the study run from?
University Hospital Antwerp (Belgium)
When is the study starting and how long is it expected to run for?
January 2025 to December 2029
Who is funding the study?
Kom op Tegen Kanker (Belgium), Stand up to Cancer, the Flemish cancer society project id-number: 13359
Who is the main contact?
Dr Melissa Konings, melissa.konings@uantwerpen.be
Contact information
Public, Scientific
Drie Eikenstraat 655
Antwerp
2650
Belgium
 ORCID ID |
0009-0001-2118-3227 |
|---|---|
| Phone | +32 (0)34368557 |
| melissa.konings@uantwerpen.be |
Principal investigator
Drie Eikenstraat 655
Antwerp
2650
Belgium
| ORCID ID |
0000-0001-6934-4168 |
|---|---|
| Phone | +32 (0)3 821 34 41 |
| Gwen.VanNuffelen@uza.be |
Scientific
Drie Eikenstraat 655
Antwerp
2650
Belgium
| ORCID ID |
0000-0002-8158-7629 |
|---|---|
| Phone | +32 (0)3 821 30 00 |
| Leen.VandenSteen@uza.be |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Prevention, Supportive care, Treatment |
| Scientific title | PRESTO-II: the effect of a hybrid version of the PRESTO-program on adherence and swallowing in head and neck cancer patients treated with (chemo)radiotherapy – a multicentre randomized trial |
| Study acronym | PRESTO-II |
| Study objectives | PRESTO-II demonstrates that the hybrid group (PRESTO-H) is non-inferior to the therapist group (PRESTO-T) regarding adherence and swallowing function, muscle strength and quality of life, in the short-term and long-term. The study will also assess the financial consequences of implementing the results of the study and the efficacy of the PRESTO-program in patients with at least 75% adherence. |
| Ethics approval(s) |
Approved 22/09/2025, Ethics committee of Antwerp University Hospital (Drie Eikenstraat 655, Antwerp, 2650, Belgium; +32 (0)3 821 38 97; ethisch.comite@uza.be), ref: 7607 |
| Health condition(s) or problem(s) studied | Head and neck cancer treated with radiotherapy or chemoradiotherapy |
| Intervention | The PRESTO-program is a 4-week prophylactic swallowing exercises (PSE) program, which commences on the first day of radiotherapy. The program is conducted on a 5-day weekly basis. The PSE consist of two evidence-based exercises, alternated on daily basis. These exercises target the main muscle groups involved in the act of swallowing: 1. Tongue strengthening exercises (TSE) are performed with the Iowa Oral Performance Instrument (IOPI), with 120 tongue presses per session, divided into twelve sets of ten repetitions. TSE will be performed since tongue strength is the main bolus-driving force. Reduced tongue strength can cause oral and pharyngeal residue and aspiration. 2. Chin tuck against resistance (CTAR) with an inflatable rubber ball positioned between the chin and the manubrium sterni. Participants are allowed to use one hand to keep the ball in position during the exercise. Patients must perform 150 chin tucks per session, divided into 30 sets of 5 repetitions. The fifth repetition is a combination of a chin-tuck with an effortful swallow. CTAR exercises will be performed since they have a significant effect on the suprahyoid muscles, with a positive effect on laryngeal elevation and upper esophageal sphincter opening. The effortful swallow will be performed since it can improve the tongue-base posterior motion, and it can increase tongue-base pharyngeal-wall pressures. The combination of chin tuck and effortful swallow is hypothesized to stimulate the pharyngeal musculature. On a weekly basis, maximal tongue muscle strength and suprahyoid muscle strength is remeasured. Patients practice at 80 % of their maximal strength (1-repetition maximum, 1RM). If this resistance is too demanding, patients can temporarily exercise at 60% of 1RM. Patients are randomly assigned to one of two groups. The PRESTO-therapist (PRESTO-T) will engage in face-to-face practice with the SLP for 5 days a week (100% of the sessions). The PRESTO-hybrid (PRESTO-H) will practice face-to-face with the SLP for 50 % of the sessions. PRESTO-H participants are following a flexible schedule, but patients should never practice for three consecutive days without the supervision of an SLP. During the first 3 months after radiotherapy (until T6), no swallowing therapy is permitted, except for patients with a FOIS of 1 or 2. Initiation after 3 months after radiotherapy is well documented and considered a real-world setting. The method of randomisation employed is minimisation. Patients are randomly assigned to one of the two groups with a 1:1 allocation. The following minimisation factors have been selected for consideration: age, treating centre, presence of baseline dysphagia, treatment and tumour site. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Biopsy proven, newly diagnosed squamous cell carcinoma of the oropharynx and hypopharynx 2. Stage III or IV (TMN8) 3. Treatment with radiotherapy or concomitant chemoradiotherapy with/without induction chemotherapy 4. Sufficient cognitive and language abilities (Montreal Cognitive Assessment - MOCA®-version 8.1 Dutch): cut-off point <22 |
| Key exclusion criteria | 1. Recurrent carcinoma or metastasis from a non-HNC carcinoma 2. Previous (chemo)radiotherapy in the head-neck region with possible impact on swallowing function 3. Major surgery in the head-neck region with possible impact on swallowing function |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/03/2028 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
02/01/2026: Study's existence confirmed by the ethics committee of Antwerp University Hospital.
