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

Last updated: July 24, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Cancer

Head And Neck Cancer

Treatment

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

Clinical Study ID

NCT05894070
2023-00838
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (innon-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: pathologicalstage I-IV (excluding M1) according to the UICC / TNM 8th ed.).

  2. ≥ 18 years of age.

  3. Treatment with curative intent, regardless of treatment modality (mono- ormultimodal). Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible. Patients withsurgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinomaof the skin and/or other surgically treated non-head and neck Tis are eligible,although the treatment was within the 6 months before enrolment.

  4. Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose andThroat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at thetime of enrolment, during the period of eligibility (6 to 30 months aftertreatment). Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible. Patients withsurgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinomaof the skin and/or other surgically treated non-head and neck Tis are eligible,although the treatment was within the 6 months before enrolment.

  5. Informed consent as documented by signature.

Exclusion

Exclusion Criteria:

  1. Total laryngectomy as primary therapy.

  2. Any local, regional, and systemic laryngeal or hypopharyngeal cancerpersistence/progression, or recurrence before enrolment. Excepted: Patients with synchronous laryngeal/hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible.

  3. Any local, regional, and systemic tumor persistence/progression, or recurrence ofsynchronous (larynx and hypopharynx included) or metachronous (before/after thediagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6months before enrolment. Excepted: Patients with surgically treated progredient or recurrent locally definedTis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/ornon-head and neck progredient or recurrent Tis.

  4. Any previously treated LSCC/HPSCC or treated second primary malignancies of thelarynx or hypopharynx before the diagnosis and treatment of the investigatedLSCC/HPSCC (= index tumor).

  5. Presence of any medical, psychological, familial, sociological, or geographicalconditions expected to potentially hamper the compliance with the study protocol.

  6. Inability to follow procedures (e.g., inability to read) or insufficient knowledgeof any project language (German and French).

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
Phase:
Study Start date:
August 02, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

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

    Bern, 3010
    Switzerland

    Active - Recruiting

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

    Zurich, 8091
    Switzerland

    Active - Recruiting

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