Laryngectomy
Conditions
Brief summary
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.
Detailed description
Primary Objective: To determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP. Secondary Objectives: 1. To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator) 2. To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator) Exploratory objectives: 1. To explore relationships between clinicodemographic features and device/TEP function 2. To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function 3. To explore relationships between oral/tracheal microbiome and device/TEP function 4. To describe novel use of prophylactic exchange of Provox® ActiValve®
Interventions
DEVICEProvox® ActiValve®
Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture 2. Using or ready for fit of indwelling voice prosthesis 3. No evidence of disease (NED) in head and neck 4. At least 6 months since cancer treatment 5. TEP tract length 4.5 to 12.5mm at time of enrollment\* * The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge).
Exclusion criteria
1. History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months) 2. History of recurrent VP extrusion (within last 12 months) 3. Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU) 4. History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months) 5. Active malignancy in head and neck and/or chest at the time of enrollment 6. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment 7. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons 8. Planned regular VP exchanges at outside facility within next 12 months 9. History of gastric pull-up reconstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTKatherine A Hutcheson, PHD
PRINCIPAL_INVESTIGATORKatherine A Hutcheson, PHD
M.D. Anderson Cancer Center
Outcome results
None listed