Robotic surgery plus daily swallowing therapy aims to keep head and neck cancer patients eating and speaking normally
NCT ID NCT07546045
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a personalized 12-week speech, swallowing, and voice rehabilitation program can help preserve swallowing function in head and neck cancer patients after minimally invasive robotic surgery. About 53 participants will be enrolled, including those having surgery for a first tumor, a recurrent tumor, or to improve swallowing after prior treatment. The program involves daily exercises with a therapist and at home, with regular check-ups over two years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITINGLausanne, 1011, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer