Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer

NCT07546045 | Not Yet Recruiting

• 1 other identifier: 2025-01892
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether an intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program can help preserve swallowing function in patients with head and neck cancer undergoing minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA). Participants will undergo the RESA surgery as part of their standard care. After surgery, they will receive a structured SSVR program for 12 weeks, including daily exercises performed both with a speech therapist and independently. The program is tailored to each patient and adapted based on regular assessments of swallowing and voice function. The study includes three groups of patients: Those having surgery for a primary tumor Those having surgery for a recurrent or second primary tumor Patients treated for laryngeal elevation to improve swallowing after previous cancer treatment The main goal is to assess whether this approach improves swallowing function measured by a validated questionnaire 12 weeks after surgery. Secondary outcomes include long-term swallowing, voice, diet, post-operative complications, surgical success, disease recurrence, survival, and quality of life. All participants will be followed for two years with regular visits at CHUV, including swallowing and voice tests, questionnaires, and imaging exams. The study is expected to provide important information on how combining minimally invasive surgery with intensive rehabilitation can benefit patients' swallowing and overall quality of life.

Conditions

Dysphagia Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Swallowing function measured by composite MDADI score

  The primary outcome is the percentage of participants reaching a composite MDADI score of 80 (cohorts 1 and 2) or 60 (cohort 3) at 12 weeks after surgery. All participants complete the MDADI questionnaire at screening and at the 12-week post-operative visit to assess swallowing function, safety, and quality of life related to dysphagia.

  12 weeks post-surgery

Secondary Outcomes (30)

• Long-term swallowing function - MDADI

  Up to 24 months post-surgery

• Dietary intake - Functional Oral Intake Scale (FOIS)

  Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)

• Dietary consistency - International Dysphagia Diet Standardisation Initiative (IDDSI)

  Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)

• Swallowing safety - Penetration-Aspiration Scale (PAS)

  Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)

• Swallow efficiency - Eisenhuber scale

  Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)

Study Arms (1)

Intensive and Personalized SSVR

EXPERIMENTAL

All participants receive a 12-week intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program following minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA). Supervised sessions with a speech therapist and unsupervised daily exercises are included.

Other: Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR)

Interventions

Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR) OTHER

Participants will receive a 12-week intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program following minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA). The program includes: * Supervised SSVR sessions (approximately 45 minutes) with a speech therapist, starting 7 days post-surgery, once per day during hospitalization, then 1-3 times per week outpatient up to week 12. * Unsupervised SSVR sessions (approximately 20 minutes) performed daily by the participant at home. * Exercises are personalized and adapted regularly based on functional assessments of swallowing and voice using FEES and VFSS exams. The goal is to improve swallowing safety and efficiency, voice quality, and overall functional outcomes.

Intensive and Personalized SSVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Indication for speech, swallowing and voice rehabilitation after surgery
• Informed consent signature
• years old or older at the time of informed consent signature

You may not qualify if:

• Inability to give informed consent
• Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
• Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule,
• Inability to memorize one analytic and one compensatory exercise at screening visit
• Participation in another study with an investigational drug or medical device within the 30 days preceding and during the present investigation,
• previous enrolment into the current study,
• contraindication to iodine contrast media (Accupaque) oral intake, i.e known anaphylaxis.

Sponsors & Collaborators

• Christian Simon: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Deglutition

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Jelena Todic

CONTACT

+41(0)79 556 08 62; jelena.todic@chuv.ch

Christian Simon

CONTACT

+41(0)79 556 54 16; christian.simon@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Otolaryngology and Head and Neck Surgery, Clinical Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)