RecruitingNot ApplicableNCT07546045

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

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


Sponsor

Christian Simon

Enrollment

53 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR) for people with dysphagia rehabilitation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntensive 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.


Locations(1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

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NCT07546045


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