mucosal head and neck cancer head and neck cancer
Conditions
Interventions
One group will receive nutritional prehabilitation and one group will receive standard care (which means they will not receive nutritional prehabilitation).
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Primary mucosal squamous cell carcinoma; - Located in the oral cavity, oropharynx, hypopharynx or larynx; - Locoregionally advanced disease defined as stage III and stage IV disease. For oropharynx malignancies the HPV-negative TNM-staging is used at the time of inclusion; - Treated with curative intent; - Low or medium risk of malnutrition based on the MUST; - Pre-treatment CT scan performed up to 30 days before treatment; - Age >=18 years; - Written informed consent.
Exclusion criteria
Exclusion criteria: - Previous surgical or radiotherapeutic treatment of the neck; - Multiple simultaneous primary malignancies; - Disability that could interfere with questionnaire fulfillment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (i.e., intra- and postoperative complications and (chemo)radiotherapy toxicity). Complications will be measured within 30 days after surgery using the Clavien-Dindo classification. Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, 6 weeks after the start of (chemo)radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported quality of life (i.e., the EAT-10, EORTC H&N35 and EORTC C30 questionnaires), recurrence, (disease-specific and overall) survival, and cost-utility and cost-effectiveness (measured using the EQ-5D-5L, adverse events, iMCQ and iPCQ). | — |
Countries
Netherlands
Contacts
Public ContactI Wegner
Universitair Medisch Centrum Groningen
Outcome results
None listed