Enteral versus parenteral feeding in adult stem cell transplantation patients with chemotherapy-induced gastro-intestinal mucositis.

Completed

Conditions: mucosal damage digestive tract
mucositis
10018849
10017943
10003018

Registration Number: NL-OMON40573

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

-Creatinine level > 150 µmol/l, creatinine clearance < 50 ml/min.
-Admission on the hematology department on Wednesday because of tube
placement during the weekend.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are changes in the nutritional status (bodyweight), and the<br /><br>severity of GI mucositis (Nijmegen Nursing Mucositis Scoring System and<br /><br>citrulline levels).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the impact on Quality-of-Life and occurrence of<br /><br>treatment-related complications (neutropenic fever, bacteraemia).</p><br>