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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Swallowing function measured by composite MDADI score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intensive and Personalized SSVR
All participants receive a 12-week intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program following minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA). Supervised sessions with a speech therapist and unsupervised daily exercises are included.
干预措施: Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR) (Other)
结局指标
主要结局
Swallowing function measured by composite MDADI score
时间窗: 12 weeks post-surgery
The primary outcome is the percentage of participants reaching a composite MDADI score of 80 (cohorts 1 and 2) or 60 (cohort 3) at 12 weeks after surgery. All participants complete the MDADI questionnaire at screening and at the 12-week post-operative visit to assess swallowing function, safety, and quality of life related to dysphagia.
次要结局
- Long-term swallowing function - MDADI(Up to 24 months post-surgery)
- Dietary intake - Functional Oral Intake Scale (FOIS)(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)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallowing safety - Penetration-Aspiration Scale (PAS)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow efficiency - Eisenhuber scale(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow Reaction Time (SRT)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Laryngeal Vestibule Closure Reaction Time (LVCrt)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Pharyngeal Transit Time (PTT)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Upper Esophageal Sphincter (UES) Opening Duration(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow amplitude - hyoid elevation (HE)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow amplitude - Laryngeal ascension amplitude(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(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow amplitude - Pharyngeal area at maximum dilation(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow amplitude - Pharyngeal constriction ratio(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow efficiency - Normalized Residue Ratio Scale valleculae (NRRSv)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Swallow efficiency - Normalized Residue Ratio Scale piriform (NRRSp)(Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24))
- Voice quality - GRBAS scale(Up to 24 months post-surgery)
- Voice quality - Maximum Phonation Time (MPT)(Up to 24 months post-surgery)
- Voice quality - Jitter (variations in signal frequency)(Up to 24 months post-surgery)
- Voice quality - Shimmer (variation in signal amplitude)(Up to 24 months post-surgery)
- Post-operative complications - Clavien-Dindo(from week 0 to 12)
- Post-operative complication - Postoperative Hemorrhage(From week 0 to week 1)
- Loco-regional recurrence(Up to 24 months post-surgery)
- Distant tumor recurrence(Up to 24 months post-surgery)
- 2nd primary head and neck cancer (HNC) control(Up to 24 months post-surgery)
- Disease-free survival (DFS)(Up to 24 months post-surgery)
- Disease-specific survival(Up to 24 months post-surgery)
- Overall survival (OS)(Up to 24 months post-surgery)
- Surgical margin status(Week 0 post-surgery)
- Quality of life - EORTC QLQ-HN43(Up to 24 months post-surgery)
研究者
Christian Simon
Head of the Department of Otolaryngology and Head and Neck Surgery, Clinical Professor
Centre Hospitalier Universitaire Vaudois