mucosal damage digestive tract mucositis
Conditions
Interventions
Patients will be given either enteral or parenteral nutrition in a randomized
fashion. EN will be administered via a naso-jejunal tube and TPN via a central
venous catheter.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients admitted to the Radboudumc for treatment with intensive chemotherapy that is known to result in clinically relevant GI mucositis will be eligible for this study. A single cohort has been pre-defined by treatment modality: - Autologous SCT with either high-dose melphalan (HDM) or carmustine, etoposide, cytarabine and melphalan (BEAM) conditioning for the treatment of multiple myeloma or (non-)Hodgkin lymphoma. - Able and willing to give written informed consent. - Treatment and follow-up at the Radboudumc during the first 6 months after SCT. - Adequate knowledge of the Dutch language. - No severe malnutrition; defined as a BMI >18 and/or a serum albumin > 20 g/L. - No pre-existing bowel diseases e.g. short bowel syndrome, Crohn*s disease, or celiac disease. - Able to follow the standard infectious protocol. - Ability to place a naso-jejunal tube. - Agrees not to use pre- and pro-biotics.
Exclusion criteria
Exclusion criteria: -Creatinine level > 150 µmol/l, creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are changes in the nutritional status (bodyweight), and the severity of GI mucositis (Nijmegen Nursing Mucositis Scoring System and citrulline levels). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the impact on Quality-of-Life and occurrence of treatment-related complications (neutropenic fever, bacteraemia). | — |
Countries
Netherlands
Outcome results
None listed