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

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

Overview

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.

Interventions

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

Primary outcome measures

• Swallowing function measured by composite MDADI score [Time frame: 12 weeks post-surgery]

Secondary outcome measures (12)

• Long-term swallowing function - MDADI [Time frame: Up to 24 months post-surgery]
• Dietary intake - Functional Oral Intake Scale (FOIS) [Time frame: 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) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallowing safety - Penetration-Aspiration Scale (PAS) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow efficiency - Eisenhuber scale [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow Reaction Time (SRT) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Laryngeal Vestibule Closure Reaction Time (LVCrt) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Pharyngeal Transit Time (PTT) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Upper Esophageal Sphincter (UES) Opening Duration [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - hyoid elevation (HE) [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - Laryngeal ascension amplitude [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - normalized maximum width of upper esophageal sphincter (UES) opening [Time frame: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]

Eligibility criteria

Inclusion criteria

• 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
• 18 years old or older at the time of informed consent signature

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne

Identifiers

NCT: NCT07546045 · 2025-01892

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗