Nutrition in adult haematology patients with GI mucositis.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24996

Enrollment

Registered

2013-11-19

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy induced mucositis enteral nutrition parenteral nutrition stem cell transplantation

Interventions

Enteral nutrition via a naso-jejunal tube (intervention) versus total parenteral nutrition via a central venous catheter (standard care).

Eligibility

Inclusion criteria

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. - 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 < 60 ml/min. • Admission on the hematology department on Wednesday because of tube placement during the weekend.

Design outcomes

Primary

Measure	Time frame
i. Nutritional status determined by change in body-weight. ii. The severity of GI mucositis as determined by citrulline levels and the Nijmegen Nursing Mucositis Scoring System, NNMSS (APPENDIX B).	—

Secondary

Measure	Time frame
i. The Quality-of-Life using the EORTC QLQ-C30 version 3.0 (APPENDIX C) and the VAS-score (APPENDIX D). ii. Body mass index (BMI) and mid-upper-arm circumference (MUAC). iii. Incidence of infectious complications and bactaeremia. iv. Inflammatory response as determined by the presence of fever, and elevated levels of C-reactive protein and interleukin-8. v. Engraftment and time to engraftment. vi. Percentage of calculated optimal quantity of tube feeding which is actually given to the patient. vii. Liver toxicity scores according to the NCI-CTCAE version 4.0. viii. Length of hospital stay	—

Measure

Time frame

i. The Quality-of-Life using the EORTC QLQ-C30 version 3.0 (APPENDIX C) and the VAS-score (APPENDIX D). ii. Body mass index (BMI) and mid-upper-arm circumference (MUAC). iii. Incidence of infectious complications and bactaeremia. iv. Inflammatory response as determined by the presence of fever, and elevated levels of C-reactive protein and interleukin-8. v. Engraftment and time to engraftment. vi. Percentage of calculated optimal quantity of tube feeding which is actually given to the patient. vii. Liver toxicity scores according to the NCI-CTCAE version 4.0. viii. Length of hospital stay

—

Contacts

Public ContactLenneke Groningen, van

Postbus 9101

lenneke.vangroningen@radboudumc.nl024-3614762

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)