Evaluation of an early postoperative nutritional intervention in patients with head and neck cancer

Not Applicable

Conditions: D48
Neoplasm of uncertain or unknown behaviour of other and unspecified sites

Registration Number: DRKS00016020

Lead Sponsor: RWTH Uniklinik Aachen Abteilung für Mund-, Kiefer- und Gesichtschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients with first-time head and neck cancer

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br><br>What? Comparison of length of stay, laboratory values, nutritional status and postoperative complications<br>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<br>How? self-developed questionnaires, laboratory values and consultation of the nutrition team

Secondary Outcome Measures

Name	Time	Method
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.<br><br>What? Comparison of physical and mental well-being between intervention and control groups<br>When? Both patients of the control and intervention groups are interviewed at the end of hospitalization and after 3 and 6 months<br>How? self-developed questionnaires