In this study, we will test which of two feeding strategies for adults during chemotherapy-induced mucositis is optimal with regards to maintaining an optimal body weight, nutritional status, gut mucosal barrier and treatment outcome (including…
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Gastrointestinal conditions NEC
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are changes in the nutritional status (bodyweight), and the
severity of GI mucositis (Nijmegen Nursing Mucositis Scoring System and
citrulline levels).
Secondary outcome
Secondary endpoints include the impact on Quality-of-Life and occurrence of
treatment-related complications (neutropenic fever, bacteraemia).
Background summary
Gastrointestinal (GI) mucositis is a severe side effect of chemo- and/or
radiotherapy and is associated with nutrient maldigestion and malabsorption.
Clinically, patients with mucositis suffer from anorexia, diarrhoea, abdominal
pain and weight loss. A standardized, validated and effective feeding strategy
for haematology patients suffering from treatment-induced mucositis is
currently lacking. However, directed nutritional support might improve the
nutritional status of mucositis patients, accelerate recuperation and increase
survival. Preclinical studies in rats, suffering from GI mucositis, showed that
amino acids and glucose could be normally absorbed especially when administered
by continuous enteral drip. The enteral regimen was superior as compared to a
parenteral regimen with regards to preservation of gut mucosa integrity.
Although there is much experience with both enteral and total parenteral
feeding in many clinical settings of patient care, in the care for adults
treated with intensive chemotherapy total parenteral nutrition (TPN) is
predominantly used. However, no evidence exists indicating superiority of TPN
over enteral nutrition (EN) with regards to improved cancer treatment outcome
(weight loss, infection incidence and survival). However EN has theoretical
benefits including the preservation of the mucosal barrier with less atrophy,
bacterial translocation and inflammation. It is easier to administer and
cheaper than TPN. Since there are no consistent data about feeding strategies
in adults with mucositis, we designed a research project to study which feeding
strategy is preferable in patients with chemotherapy-induced mucositis.
Study objective
In this study, we will test which of two feeding strategies for adults during
chemotherapy-induced mucositis is optimal with regards to maintaining an
optimal body weight, nutritional status, gut mucosal barrier and treatment
outcome (including complications):
1. An elementary tube diet (Survimed*), containing simple macronutrients,
administered by continuous enteral drip through a naso-jejunal tube.
2. Total parenteral nutrition administered through a central venous catheter.
Study design
The study will compare two feeding strategies (elementary tube feeding versus
total parenteral feeding) in a randomized design. Blinding is not possible due
to the nature of the two study strategies (enteral versus parenteral
nutrition). TPN is the current clinical practice in adults and therefore
designated the standard arm.
Intervention
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.
Study burden and risks
Low risk.
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46459.091.13 |
| Other | TC=4270 |