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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia Rehabilitation
• Intervention / Treatment: Other: Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR)

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jelena Todic; Phone Number: +41(0)79 556 08 62; Email: jelena.todic@chuv.ch
• Study Contact Backup: Name: Christian Simon; Phone Number: +41(0)79 556 54 16; Email: christian.simon@chuv.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois (CHUV)
    • Contact: Jelena Todic, MD; Phone Number: +41(0)795560862; Email: jelena.todic@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intensive and Personalized SSVR; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term swallowing function - MDADI	Composite MDADI scores will be assessed at screening, 6, 12, and 24 months post-surgery to evaluate the long-term effect of intensive and personalized SSVR on swallowing function.	Up to 24 months post-surgery
Dietary intake - Functional Oral Intake Scale (FOIS)	Dietary intake will be assessed using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from 1 to 7. Score is rated on 7 when patient tolerates total normal diet with no restrictions.	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)	Dietary consistency will be assessed using the International Dysphagia Diet Standardisation Initiative (IDDSI) framework, which classifies food and drink textures into levels ranging from 0 (thin liquids) to 7 (regular foods). Higher levels indicate more advanced diet textures.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallowing safety - Penetration-Aspiration Scale (PAS)	Swallow safety will be assessed using the Penetration-Aspiration Scale (PAS). It is an 8-point scale (no unit) used to characterize the depth and response to airway invasion during swallowing. Higher scores indicate worse swallow safety.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow efficiency - Eisenhuber scale	Qualitative parameters will be assessed using VFSS: recording of the total number of swallows per bolus, evaluation of residue in the valleculae and piriform sinuses with the Eisenhuber scale (0-3, no unit).	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow Reaction Time (SRT)	Swallow reaction time (SRT) will be quantitatively assessed using videofluoroscopic swallow study (VFSS). Unit of Measure: Milliseconds (ms)	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Laryngeal Vestibule Closure Reaction Time (LVCrt)	Laryngeal vestibule closure reaction time (LVCrt) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms).	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Pharyngeal Transit Time (PTT)	Pharyngeal transit time (PTT) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms).	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Upper Esophageal Sphincter (UES) Opening Duration	Upper esophageal sphincter (UES) opening duration will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms)	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow amplitude - hyoid elevation (HE)	Hyoid elevation (HE) in millimeter (mm) will be assessed using VFSS.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow amplitude - Laryngeal ascension amplitude	Laryngeal ascension amplitude (mm) will be assessed using VFSS.	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	normalized maximum width of upper esophageal sphincter (UES) opening (%) will be assessed using VFSS.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow amplitude - Pharyngeal area at maximum dilation	Pharyngeal area at maximum dilation (cm²) will be assessed using VFSS.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow amplitude - Pharyngeal constriction ratio	Pharyngeal constriction ratio (PCR, %) will be assessed using VFSS.	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow efficiency - Normalized Residue Ratio Scale valleculae (NRRSv)	Swallow efficiency: measured with the Normalized Residue Ratio Scale valleculae (NRRSv)	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Swallow efficiency - Normalized Residue Ratio Scale piriform (NRRSp)	Swallow efficiency: measured with the Normalized Residue Ratio Scale piriform (NRRSp)	Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)
Voice quality - GRBAS scale	Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the GRBAS scale : (G(rade) of hoarseness, R(oughness), B(reathliness), A(esthenia) weakness, and S(train).	Up to 24 months post-surgery
Voice quality - Maximum Phonation Time (MPT)	Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Maximum Phonation Time (MPT) (seconds).	Up to 24 months post-surgery
Voice quality - Jitter (variations in signal frequency)	Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Jitter (variations in signal frequency) %.	Up to 24 months post-surgery
Voice quality - Shimmer (variation in signal amplitude)	Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Shimmer (variation in signal amplitude) %.	Up to 24 months post-surgery
Post-operative complications - Clavien-Dindo	Post-operative complications will be assessed using the Clavien-Dindo classification, a grading system ranging of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) and if the patient suffers from a complication at the time of discharge, the suffix "d" (for "disability") is added to the respective grade of complication. The grade I corresponds to any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological intervention and the grade V corresponds to the death of the patient.	from week 0 to 12
Post-operative complication - Postoperative Hemorrhage	Classification System for Postoperative Hemorrhage is graded as normal, minor, intermediate, major, or severe. The definition of normal is patient noting the presence of blood tinged mucus, flecks of blood, brown mucus, or red streaks, and the severe bleeding corresponds to bleeding resulting in life-threatening medical complications.	From week 0 to week 1
Loco-regional recurrence	Local-regional control is defined as the time interval between the date of the 3-month mandatory imaging after the surgery and the date of local disease is detected. Local recurrence is defined as recurrence at the original primary tumor subsite or within 2 cm of distance from the primary tumor site. Regional recurrence is defined as recurrence at the cervical lymph node. The Time to first loco-regional recurrence (months) is assessed for cohorts 1 and 2.	Up to 24 months post-surgery
Distant tumor recurrence	distant control is defined as the time interval between the date of the 3-month mandatory imaging if the patient after the surgery and the first date when distant disease is detected. Distant recurrence is defined as recurrence not considered as local or regional. Time to first distant recurrence (months) is assessed for cohorts 1 and 2.	Up to 24 months post-surgery
2nd primary head and neck cancer (HNC) control	Second primary head and neck cancer control is defined as the time interval between the date of surgery and the date of diagnosis of a second cancer in the head and neck region, but outside the original primary tumor subsite (months) for cohorts 1 and 2.	Up to 24 months post-surgery
Disease-free survival (DFS)	Disease-free survival is defined as the time interval between the date of surgery and tumor recurrence or death from any cause (months) for cohort 1 and 2.	Up to 24 months post-surgery
Disease-specific survival	Disease-specific survival is defined as the time interval between the date of surgery and the date of death due to original primary disease (months) for cohort 1 and 2.	Up to 24 months post-surgery
Overall survival (OS)	Overall survival is defined as the time interval between the date of surgery and the date of death from any cause (months) for cohort 1 and 2.	Up to 24 months post-surgery
Surgical margin status	Percentage of participants with negative (>3 mm), close (1-3 mm), and positive (<1 mm) surgical margins will be recorded post-surgery.	Week 0 post-surgery
Quality of life - EORTC QLQ-HN43	Participants will complete the EORTC QLQ-HN43 questionnaire at screening, week 12, and months 6, 12, 24 to assess health-related quality of life.	Up to 24 months post-surgery

Collaborators and Investigators

• Sponsor: Christian Simon

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Deglutition
• Other Study ID Numbers: 2025-01892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No