NCT07546045Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 12.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 53 (tervezett)
- Első benyújtás
- 2026. márc. 31.
- Kezdés
- 2026. máj.
- Elsődleges befejezés
- 2028. aug.
- Fő szponzor
- Christian Simon
- Betegségek
- Fej-nyaki daganatok
- NCT-szám
- NCT07546045
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 53
- 2026. máj. és az elsődleges befejezés (2028. aug.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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,
Más betegség
- Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule,
Egyéb
- Inability to give informed consent
- Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
- Inability to memorize one analytic and one compensatory exercise at screening visit
- contraindication to iodine contrast media (Accupaque) oral intake, i.e known anaphylaxis.
Kiket keres a vizsgálat
- Patients scheduled for a surgery with robotic-assisted extended "Sistrunk" approach - multiport (RESA) with the Da Vinci Xi or SP robotic system for:
- 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
- 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
- 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
- Indication for speech, swallowing and voice rehabilitation after surgery
- Informed consent signature
- 18 years old or older at the time of informed consent signature
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Lausanne | Svájc | Toboroz |
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