D48
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with first-time head and neck cancer
Exclusion criteria
Exclusion criteria: Exclusion criteria are refusal of study participation, recurrences, condition after radiotherapy and / or chemotherapy, patients with manifest malnutrition (exclusion after analysis of BMI, laboratory values, nutrition score) as well as other diseases that influence food intake in quality and / or quantity (eg PEG agency counted). Minors, pregnant and incapacitated patients are also excluded from participating in the study. Furthermore, a significantly reduced physical or emotional general condition is an exclusion criterion. Should the patients wish at any time to discontinue the study, this wish will be fulfilled immediately.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in the subjective complication experienced by the patient after the procedure / surgery. There is a stratification according to the type and severity of the measures taken. The aim is to evaluate the postoperative nutritional support of patients with head and neck cancer during hospitalization and up to six months post-op. What? Comparison of length of stay, laboratory values, nutritional status and postoperative complications When? Both patients of the control and intervention groups are interviewed at the end of the inpatient stay and after 3 and 6 months, and the nutritional status including laboratory parameters is determined How? self-developed questionnaires, laboratory values and consultation of the nutrition team | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are differences in nutritional status, length of stay, specific blood parameters, BIA or BMI at the time of follow-up after 3 and 6 months, respectively. It also compares the physical and mental well-being of the patients in the Intervention- and control groups. What? Comparison of physical and mental well-being between intervention and control groups When? Both patients of the control and intervention groups are interviewed at the end of hospitalization and after 3 and 6 months How? self-developed questionnaires | — |
Countries
Germany
Contacts
RWTH Uniklinik Aachen Abteilung für Mund-, Kiefer- und Gesichtschirurgie