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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05894070

Studienbeginn:
August 2023

Letztes Update:
09.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Laryngeal Neoplasms, Hypopharyngeal Neoplasms, Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Insel Gruppe AG, University Hospital Bern

Collaborator:
-

Studienleiter

Roland Giger, Prof.
Principal Investigator
Inselspital, Bern University Hospital

Kontakt

Roland Giger, Prof.
Kontakt:
Phone: +41 31 632 29 31
E-Mail: roland.giger@insel.ch» Kontaktdaten anzeigen

Miranda Visini, Dr. med.
Kontakt:
Phone: +41 31 632 88 59
E-Mail: miranda.visini@insel.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Roland Giger, Prof.
Phone: +41 31 632 29 31
E-Mail: roland.giger@insel.ch

Miranda Visini, Dr. med.
Phone: +41 31 632 88 59
E-Mail: miranda.visini@insel.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

1. Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire (Time Frame - 3-18 months):
The number of completed visits/exams out of all scheduled visits/exams.

2. Recruitment rate (Time Frame - 0-18 months):
Recruitment rate (number of enrolled participants per year).

Secondary outcome:

1. Subjective changes in voice (Time Frame - 0-18 months):
Subjective changes in voice assessed by the voice handicap index-30 (VHI-30).

2. Objective changes in voice 1 (Time Frame - 0-18 months):
Changes in Roughness - Breathiness - Hoarseness (RBH).

3. Objective changes in voice 2 (Time Frame - 0-18 months):
Changes in Jitter and Shimmer (JS).

4. Objective changes in voice 3 (Time Frame - 0-18 months):
Changes in Glottal-to-Noise Excitation Ratio (GNE).

5. Objective changes in voice 4 (Time Frame - 0-18 months):
Changes in Singing Power Ratio (SPR).

6. Recurrences of the index tumor (Time Frame - 0-18 months):
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.

7. Recurrences in other localizations (Time Frame - 0-18 months):
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.

8. Second primary malignancies in the larynx/hypopharynx (Time Frame - 0-18 months):
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.

9. Second primary malignancies in other localizations (Time Frame - 0-18 months):
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.

10. Composite of clinical events (Time Frame - 0-18 months):
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.

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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