The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical/radiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) / Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC / TNM 8th ed.).
≥ 18 years of age.
Treatment with curative intent, regardless of treatment modality (mono- or multimodal).
Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).
Disqualifiers
Total laryngectomy as primary therapy.
Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence/progression, or recurrence before enrolment.
Any local, regional, and systemic tumor persistence/progression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6 months before enrolment.
Any previously treated LSCC/HPSCC or treated second primary malignancies of the larynx or hypopharynx before the diagnosis and treatment of the investigated LSCC/HPSCC (= index tumor).
Trial population
The anticipated study population are patients with LSCC and HPSCC who have successfully completed curative, organ-preserving primary treatment and did not show tumor persistence, recurrence, or second primary malignancy prior to the recruitment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
Other interventionThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire
The number of completed visits/exams out of all scheduled visits/exams.
Time frame
3-21 months2
Recruitment rate
Recruitment rate (number of enrolled participants per year).
Time frame
0-21 monthsSecondary outcomes
1
Subjective changes in voice
Subjective changes in voice assessed by the voice handicap index-30 (VHI-30).
Time frame
0-21 months2
Objective changes in voice 1
Changes in Roughness - Breathiness - Hoarseness (RBH).
Time frame
0-21 months3
Objective changes in voice 2
Changes in Jitter and Shimmer (JS).
Time frame
0-21 months4
Objective changes in voice 3
Changes in Glottal-to-Noise Excitation Ratio (GNE).
Time frame
0-21 monthsSponsors and contacts
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Source ClinicalTrials.gov