RecruitingNCT05894070

The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer

The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

100 participants

Start Date

Aug 2, 2023

Study Type

OBSERVATIONAL

Conditions

Hypopharyngeal Cancer Laryngeal Cancer

Summary

The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether voice recordings and analysis can be used as a simple, non-invasive tool to detect if laryngeal (voice box) or hypopharyngeal (throat) cancer has come back after treatment. **You may be eligible if...** - You have been diagnosed with confirmed cancer of the larynx or hypopharynx (stage I–IV, no distant spread) - You have received treatment (surgery and/or radiation) for this cancer **You may NOT be eligible if...** - Your cancer has spread to distant organs (M1) - You have not been treated for your cancer yet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVoice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire

The following speech samples will be recorded from the study participants: * Standardized, phonetically balanced text * Sustained, modulated production of five vowels * Picture description * Diadochokinetic exercise. Before starting speech recording, the participant fills in a questionnaire consisting of: * Health barometer * Self-rating in terms of stress/fatigue/emotional status. An Ear, Nose and Throat examination incl. transnasal fiberendoscopy is performed at each visit. The investigators will assess the vocal folds/aryepiglottic folds for the presence of paralysis or reduced mobility, as well as the presence of scar/synechia, edema, erythro-/leukoplakia, or a cancer-suspicious lesion/mass in the larynx/hypopharynx or a chondroradionecrosis in the larynx. Additionally, it will be assessed, if a tracheotomy canula or a nasogastric tube is in place or was used since the last visit. Furthermore, the investigators will ask the patients to fill out the VHI-30.

Locations(2)

Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital

Bern, Switzerland

Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich

Zurich, Switzerland

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NCT05894070

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