Laryngeal removal Laryngecomie
Conditions
Interventions
A moderate to high-intensity personalized physical exercise intervention
combined with a nutritional intervention will take place in 7 patients 3 to 5
weeks prior to their total laryngectomy.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subject must undergo a laryngectomy • Low skeletal muscle mass (SMM) (see also paragraph 8.1.3), based on CT or MRI scans of the head and neck area at level C3. • Karnofsky Performance status >60 • Able to walk >=6 m without a mobility aid • >=18 years • Sufficient Dutch writing and reading skills
Exclusion criteria
Exclusion criteria: • Patients exercising more than in the prescribed physical exercise intervention of this study • For patients participating in the physical exercise and nutritional intervention:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence and compliance of the physical exercise intervention and the participants* experiences of the physical exercise intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Recruitment of patients * Retention rate * Compliance with nutritional prescription * Physical fitness (6MWT, SRT) * Physical muscle strength (grip strength, lower and upper muscle strength, 30s-SCT, 8-RM). * Physical activity (SQUASH) * Body composition (FFM by BIA, BMI) * Nutritional status (PG-SGA). * Quality of life (EORTC-QLQ-C30, EORTC-QLQ-H&N35, EQ-5D-5L) * Fatigue (MFI) * Surgical complications and adverse events (Clavien-Dindo classification and adverse events until 3 to 4 weeks after laryngectomy, CTCAE). | — |
Countries
Netherlands
Contacts
Public ContactC.M. Speksnijder
Universitair Medisch Centrum Utrecht
Outcome results
None listed