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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive and Personalized SSVR | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive and Personalized Speech, Swallowing, and Voice Rehabilitation (SSVR) | Other | 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:
The goal is to improve swallowing safety and efficiency, voice quality, and overall functional outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing function measured by composite MDADI score | 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. | 12 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term swallowing function - MDADI | Composite MDADI scores will be assessed at screening, 6, 12, and 24 months post-surgery to evaluate the long-term effect of intensive and personalized SSVR on swallowing function. | Up to 24 months post-surgery |
| Dietary intake - Functional Oral Intake Scale (FOIS) |
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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:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jelena Todic | Contact | +41(0)79 556 08 62 | jelena.todic@chuv.ch | |
| Christian Simon | Contact | +41(0)79 556 54 16 | christian.simon@chuv.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D003679 | Deglutition |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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Dietary intake will be assessed using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from 1 to 7. Score is rated on 7 when patient tolerates total normal diet with no restrictions. |
| 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) | Dietary consistency will be assessed using the International Dysphagia Diet Standardisation Initiative (IDDSI) framework, which classifies food and drink textures into levels ranging from 0 (thin liquids) to 7 (regular foods). Higher levels indicate more advanced diet textures. | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallowing safety - Penetration-Aspiration Scale (PAS) | Swallow safety will be assessed using the Penetration-Aspiration Scale (PAS). It is an 8-point scale (no unit) used to characterize the depth and response to airway invasion during swallowing. Higher scores indicate worse swallow safety. | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallow efficiency - Eisenhuber scale | Qualitative parameters will be assessed using VFSS: recording of the total number of swallows per bolus, evaluation of residue in the valleculae and piriform sinuses with the Eisenhuber scale (0-3, no unit). | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallow Reaction Time (SRT) | Swallow reaction time (SRT) will be quantitatively assessed using videofluoroscopic swallow study (VFSS). Unit of Measure: Milliseconds (ms) | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Laryngeal Vestibule Closure Reaction Time (LVCrt) | Laryngeal vestibule closure reaction time (LVCrt) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms). | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Pharyngeal Transit Time (PTT) | Pharyngeal transit time (PTT) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms). | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Upper Esophageal Sphincter (UES) Opening Duration | Upper esophageal sphincter (UES) opening duration will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms) | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallow amplitude - hyoid elevation (HE) | Hyoid elevation (HE) in millimeter (mm) will be assessed using VFSS. | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallow amplitude - Laryngeal ascension amplitude | Laryngeal ascension amplitude (mm) will be assessed using VFSS. | 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 | normalized maximum width of upper esophageal sphincter (UES) opening (%) will be assessed using VFSS. | 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 | Pharyngeal area at maximum dilation (cm²) will be assessed using VFSS. | Up to 24 months post-surgery (assessed at screening, weeks 1, 4, 12, and months 6, 12, 24) |
| Swallow amplitude - Pharyngeal constriction ratio | Pharyngeal constriction ratio (PCR, %) will be assessed using VFSS. | 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) | Swallow efficiency: measured with the 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) | Swallow efficiency: measured with the 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 | Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the GRBAS scale : (G(rade) of hoarseness, R(oughness), B(reathliness), A(esthenia) weakness, and S(train). | Up to 24 months post-surgery |
| Voice quality - Maximum Phonation Time (MPT) | Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Maximum Phonation Time (MPT) (seconds). | Up to 24 months post-surgery |
| Voice quality - Jitter (variations in signal frequency) | Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Jitter (variations in signal frequency) %. | Up to 24 months post-surgery |
| Voice quality - Shimmer (variation in signal amplitude) | Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Shimmer (variation in signal amplitude) %. | Up to 24 months post-surgery |
| Post-operative complications - Clavien-Dindo | Post-operative complications will be assessed using the Clavien-Dindo classification, a grading system ranging of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) and if the patient suffers from a complication at the time of discharge, the suffix "d" (for "disability") is added to the respective grade of complication. The grade I corresponds to any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological intervention and the grade V corresponds to the death of the patient. | from week 0 to 12 |
| Post-operative complication - Postoperative Hemorrhage | Classification System for Postoperative Hemorrhage is graded as normal, minor, intermediate, major, or severe. The definition of normal is patient noting the presence of blood tinged mucus, flecks of blood, brown mucus, or red streaks, and the severe bleeding corresponds to bleeding resulting in life-threatening medical complications. | From week 0 to week 1 |
| Loco-regional recurrence | Local-regional control is defined as the time interval between the date of the 3-month mandatory imaging after the surgery and the date of local disease is detected. Local recurrence is defined as recurrence at the original primary tumor subsite or within 2 cm of distance from the primary tumor site. Regional recurrence is defined as recurrence at the cervical lymph node. The Time to first loco-regional recurrence (months) is assessed for cohorts 1 and 2. | Up to 24 months post-surgery |
| Distant tumor recurrence | distant control is defined as the time interval between the date of the 3-month mandatory imaging if the patient after the surgery and the first date when distant disease is detected. Distant recurrence is defined as recurrence not considered as local or regional. Time to first distant recurrence (months) is assessed for cohorts 1 and 2. | Up to 24 months post-surgery |
| 2nd primary head and neck cancer (HNC) control | Second primary head and neck cancer control is defined as the time interval between the date of surgery and the date of diagnosis of a second cancer in the head and neck region, but outside the original primary tumor subsite (months) for cohorts 1 and 2. | Up to 24 months post-surgery |
| Disease-free survival (DFS) | Disease-free survival is defined as the time interval between the date of surgery and tumor recurrence or death from any cause (months) for cohort 1 and 2. | Up to 24 months post-surgery |
| Disease-specific survival | Disease-specific survival is defined as the time interval between the date of surgery and the date of death due to original primary disease (months) for cohort 1 and 2. | Up to 24 months post-surgery |
| Overall survival (OS) | Overall survival is defined as the time interval between the date of surgery and the date of death from any cause (months) for cohort 1 and 2. | Up to 24 months post-surgery |
| Surgical margin status | Percentage of participants with negative (>3 mm), close (1-3 mm), and positive (<1 mm) surgical margins will be recorded post-surgery. | Week 0 post-surgery |
| Quality of life - EORTC QLQ-HN43 | Participants will complete the EORTC QLQ-HN43 questionnaire at screening, week 12, and months 6, 12, 24 to assess health-related quality of life. | Up to 24 months post-surgery |