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

NCT05894070 | Recruiting

• 1 other identifier: 2023-00838
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Laryngeal Cancer; Hypopharyngeal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  3-21 months

• Recruitment rate

  Recruitment rate (number of enrolled participants per year).

  0-21 months

Secondary Outcomes (10)

• Subjective changes in voice

  0-21 months

• Objective changes in voice 1

  0-21 months

• Objective changes in voice 2

  0-21 months

• Objective changes in voice 3

  0-21 months

• Objective changes in voice 4

  0-21 months

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).
• Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.
• 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).
• Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.
• Informed consent as documented by signature.

You may not qualify if:

• Total laryngectomy as primary therapy.
• Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence/progression, or recurrence before enrolment.
• Excepted: Patients with synchronous laryngeal/hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.
• 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.
• Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or non-head and neck progredient or recurrent Tis.
• 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).
• Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.
• Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

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

Bern, 3010, Switzerland

RECRUITING

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

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Roland Giger, Prof.

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Giger, Prof.

CONTACT

+41 31 632 29 31; roland.giger@insel.ch

Miranda Visini, Dr. med.

CONTACT

+41 31 632 88 59; miranda.visini@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: August 2, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)