utrition in adult haematology patients with GI mucositis.
Completed
- Conditions
- Chemotherapy induced mucositisenteral nutritionparenteral nutritionstem cell transplantation
- Registration Number
- NL-OMON24996
- Lead Sponsor
- Radboudumc Nijmegen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Adult patients above the age of 18 able to undergo an autologous SCT with HDM or BEAM.
- Able and willing to give written informed consent.
Exclusion Criteria
•Creatinine level > 150 µmol/l, creatinine clearance < 60 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 i. Nutritional status determined by change in body-weight.<br /><br>ii. The severity of GI mucositis as determined by citrulline levels and the Nijmegen Nursing Mucositis Scoring System, NNMSS (APPENDIX B). <br>
- Secondary Outcome Measures
Name Time Method i. The Quality-of-Life using the EORTC QLQ-C30 version 3.0 (APPENDIX C) and the VAS-score (APPENDIX D).<br /><br>ii. Body mass index (BMI) and mid-upper-arm circumference (MUAC).<br /><br>iii. Incidence of infectious complications and bactaeremia.<br /><br>iv. Inflammatory response as determined by the presence of fever, and elevated levels of C-reactive protein and interleukin-8.<br /><br>v. Engraftment and time to engraftment.<br /><br>vi. Percentage of calculated optimal quantity of tube feeding which is actually given to the patient. <br /><br>vii. Liver toxicity scores according to the NCI-CTCAE version 4.0. <br /><br>viii. Length of hospital stay<br /><br>