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

NCT07546045 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-05-12

No results posted yet for this study

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

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 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.

Sponsors & Collaborators

  • Christian Simon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-08-31
Completion
2030-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546045 on ClinicalTrials.gov