Personalized rehabilitation to preserve swallowing after organ-preserving robotic RESA surgery
Official title: Intensive Personalized Rehabilitation Combined to Organ-Preserving Robotic-Assisted Extended "Sistrunk" Approach (RESA) to Preserve Swallowing in Head and Neck Cancer Patients: A Monocentric Clinical Trial
Run by Centre Hospitalier Universitaire Vaudois · NCT07546045 · Data updated 2026-11-12
This program will try a 12-week intensive, customized speech, swallowing, and voice rehabilitation for people having minimally invasive robotic RESA surgery for head and neck cancer to help preserve swallowing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 53 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | August 2028 |
| Study ends | May 2030 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07546045 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for a multiport robotic-assisted extended Sistrunk (RESA) resection using the Da Vinci Xi or SP system for specified squamous cell carcinomas of the oropharynx, hypopharynx, supraglottis, or glottis (per protocol T stages), including primary or recurrent/second primary tumors, or those undergoing laryngeal elevation to improve swallowing after prior treatment are ideal candidates.
✕Probably not a fit
Patients with vocal cord fixation, tumors beyond the specified T stages, non-squamous histology, those not undergoing RESA, or individuals unable to participate in an intensive 12-week rehabilitation program (for example due to severe comorbidity or cognitive impairment) are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project tests whether a 12-week intensive, personalized speech, swallowing, and voice rehabilitation (SSVR) program can preserve swallowing after minimally invasive robotic-assisted extended Sistrunk (RESA) surgery. All participants receive RESA as part of standard care and then follow a structured SSVR program with daily exercises guided by a speech therapist and performed independently at home. Rehabilitation is tailored to each patient and adapted based on regular assessments of swallowing and voice function. The study enrolls three cohorts—primary tumor resections, recurrent or second primary resections, and patients treated with laryngeal elevation after prior cancer therapy—with the primary outcome measured by a validated swallowing questionnaire at 12 weeks.
Why it matters
Potential benefit: If successful, this approach could help patients keep or improve swallowing after RESA surgery, reducing the need for feeding tubes and lowering aspiration-related complications.
How similar studies have gone: Intensive, targeted swallowing and speech rehabilitation has shown benefit in other head and neck cancer populations, but combining such programs specifically after organ-preserving RESA surgery is relatively novel and less extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients scheduled for a surgery with robotic-assisted extended "Sistrunk" approach - multiport (RESA) with the Da Vinci Xi or SP robotic system for: a. a primary tumor resection of (cohort 1) i. oropharyngeal (base of tongue with involvement of the vallecula) (T1-3) or ii. hypopharyngeal (piriform sinus, posterior hypopharyngeal wall, postcricoid region) (T1-2) or iii. supraglottis (epiglottis, false cord, aryepiglottic fold) (T1-3) (no cord fixation) or iv. glottis (HPV + and HPV -) squamous cell carcinoma of the upper aerodigestive tract, or b. a tumor resection of recurrent or second primary of (cohort 2) i. oropharyngeal (base of tongue with involvement of the vallecula) (T1-3) ii. hypopharyngeal (piriform sinus, posterior hypopharyngeal wall, postcricoid region) (T1-2) iii. supraglottis (epiglottis, false cord, aryepiglottic fold) (T1-3) (no cord fixation) iv. glottis (HPV + and HPV -) squamous cell carcinoma of the upper aerodigestive tract, or c. a laryngeal elevation aiming at improving dysphagia (cohort 3) i. in patients formerly treated for HNC and, ii. free of HNC for at least 2 years and, iii. with preserved vocal cord mobility assessed by videostroboscopy and, iv. with a MDADI ≤60 assessed at screening visit, v. with a PAS ≥ 5 assessed at screening visit by FEES vi. a minimum of 20 speech, swallowing and voice rehabilitation therapy sessions have already been carried out 2. Indication for speech, swallowing and voice rehabilitation after surgery 3. Informed consent signature 4. 18 years old or older at the time of informed consent signature Exclusion Criteria: 1. Inability to give informed consent 2. Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else) 3. Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule, 4. Inability to memorize one analytic and one compensatory exercise at screening visit 5. Participation in another study with an investigational drug or medical device within the 30 days preceding and during the present investigation, 6. previous enrolment into the current study, 7. contraindication to iodine contrast media (Accupaque) oral intake, i.e known anaphylaxis.
Where it's running
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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland Recruiting
Study contacts
- Study coordinator: Jelena Todic
- Email: jelena.todic@chuv.ch
- Phone: +41(0)79 556 08 62
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.