Using voice recordings to monitor laryngeal and hypopharyngeal cancer recurrence

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

This study is testing if regular voice recordings can help keep track of cancer returning in patients who have finished treatment for laryngeal and hypopharyngeal cancer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 2 sites (Bern and 1 other locations)
• Trial ID: NCT05894070 on ClinicalTrials.gov

What this trial studies

This observational study aims to monitor patients with laryngeal and hypopharyngeal squamous cell carcinoma who have completed curative treatment, excluding those who underwent total laryngectomy. Participants will provide voice recordings every three months and undergo fiberendoscopic examinations of the larynx and hypopharynx for at least six months. Additionally, patients will complete the Voice Handicap Index-30 questionnaire to assess their vocal problems. The primary goal is to evaluate the feasibility and compliance of long-term voice monitoring in these patients during follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of laryngeal or hypopharyngeal squamous cell carcinoma who have completed curative treatment.

Not a fit: Patients who have undergone total laryngectomy or those with metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of cancer recurrence through regular voice monitoring.

How similar studies have performed: While the use of voice monitoring in cancer follow-up is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. 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.).
2. ≥ 18 years of age.
3. 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.
4. 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.
5. Informed consent as documented by signature.

Exclusion Criteria:

1. Total laryngectomy as primary therapy.
2. 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.
3. 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.
4. 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).
5. Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.
6. Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).

Where this trial is running

Bern and 1 other locations

• Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
• Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich — Zurich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Roland Giger, Prof. — Inselspital, Bern University Hospital
• Study coordinator: Roland Giger, Prof.

Conditions Laryngeal Cancer; Hypopharyngeal Cancer