Prophylactic swallowing exercise protocol in head and neck cancer patients: combination of self-directed and supervised training

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11188227

Enrollment

150

Registered

2026-02-26

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

Head and neck cancer treated with radiotherapy or chemoradiotherapy Cancer

Interventions

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 t

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Countries

Belgium

Contacts

Public ContactMelissa Konings

melissa.konings@uantwerpen.be+32 (0)34368557

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026