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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Swallowing function measured by composite MDADI score [Срок оценки: 12 weeks post-surgery]

Вторичные конечные точки (12)

• Long-term swallowing function - MDADI [Срок оценки: Up to 24 months post-surgery]
• Dietary intake - Functional Oral Intake Scale (FOIS) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Dietary consistency - International Dysphagia Diet Standardisation Initiative (IDDSI) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallowing safety - Penetration-Aspiration Scale (PAS) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow efficiency - Eisenhuber scale [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow Reaction Time (SRT) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Laryngeal Vestibule Closure Reaction Time (LVCrt) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Pharyngeal Transit Time (PTT) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Upper Esophageal Sphincter (UES) Opening Duration [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - hyoid elevation (HE) [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - Laryngeal ascension amplitude [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]
• Swallow amplitude - normalized maximum width of upper esophageal sphincter (UES) opening [Срок оценки: Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24)]

Критерии участия

Критерии включения

• 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

• Indication for speech, swallowing and voice rehabilitation after surgery
• Informed consent signature
• 18 years old or older at the time of informed consent signature

Критерии исключения

• Inability to give informed consent
• Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne

Идентификаторы

NCT: NCT07546045 · 2025-01892

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗