Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer (NCT07546045) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer
Switzerland53 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Swallowing function measured by composite MDADI score
. 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.