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

Laryngeal Cancer Clinical Trial

— VoiceDetect  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894070
• Other study ID #: 2023-00838
• Status: Recruiting
• Start date: August 2, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Roland Giger, Prof.
• Phone: +41 31 632 29 31
• Email: roland.giger[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Laryngeal Cancer
• Laryngeal Neoplasms
• Recurrence

Intervention

Other:
• Voice 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

Country	Name	City	State
Switzerland	Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-18 months
Primary	Recruitment rate	Recruitment rate (number of enrolled participants per year).	0-18 months
Secondary	Subjective changes in voice	Subjective changes in voice assessed by the voice handicap index-30 (VHI-30).	0-18 months
Secondary	Objective changes in voice 1	Changes in Roughness - Breathiness - Hoarseness (RBH).	0-18 months
Secondary	Objective changes in voice 2	Changes in Jitter and Shimmer (JS).	0-18 months
Secondary	Objective changes in voice 3	Changes in Glottal-to-Noise Excitation Ratio (GNE).	0-18 months
Secondary	Objective changes in voice 4	Changes in Singing Power Ratio (SPR).	0-18 months
Secondary	Recurrences of the index tumor	Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences of the initially treated LSCC/HPSCC.; Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.	0-18 months
Secondary	Recurrences in other localizations	Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences in other localizations.; Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.	0-18 months
Secondary	Second primary malignancies in the larynx/hypopharynx	Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in the larynx/hypopharynx.; Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.	0-18 months
Secondary	Second primary malignancies in other localizations	Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in other localizations.; Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.	0-18 months
Secondary	Composite of clinical events	Composite endpoint: Number/Percentage of patients with laryngeal/hypopharyngeal recurrence, second primary malignancy, edema, scar/synechia, erythro-/leukoplakia, laryngeal chondroradionecrosis and hypomobility/ paralysis determined by fiber-endoscopy.	0-18 months