Effect of Individualized Nutrition on Quality of Life Clinical Trial
Official title:
Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Aim
Allogeneic stem cell transplantation (allo-SCT) combined with several cycles of intensive
chemotherapy is the only curative treatment for several malignant blood diseases. Most
allo-SCT patients who are treated with intensive chemotherapy often have reduced nutritional
status. Several studies have evaluated the effect of different nutrition intervention for
allo-SCT patients, but there have not been found evidence-based recommendations for energy
requirements, use of enteral nutrition (EN) and/or parenteral nutrition (PN). We are not
aware of studies using QoL as end-point among allo-SCT patients allocated to specific
nutrition intervention.
Main hypothesis:
Patients who receive individualized nutrition have better "global" QoL assessed with the
European Organisation for Research and Treatment in Cancer (EORTC) QLQ-HDC29 tool three
months after SCT
Sub-hypotheses:
Patients who receive individualized nutrition have:
i) less often oral mucositis grade 3-4. ii) better nutrition status iii) decreased length of
hospital stay, less episodes with fever, earlier engraftment and less often acute graft
versus host disease (GVHD) grade 3-4, and iv) better main QoL scores on the scale for
physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea three
months after allogeneic SCT, compared to the control group.
Patients and methods A minimum sample of 100 patients will be included in the study. The
patients enrolled in the study will be randomly assigned to the intervention- or control
group. The patients in the intervention group will receive a therapeutic diet in combination
with tube feeding with an additional PN if the estimated requirements by the enteral route is
lower than reference values. The patients in the control group will receive nutrition support
after established routine, first by the oral route, later by the PN route.
Patients and methods
A minimum sample of 100 patients will be included in the study. This is the result of a power
calculation where a difference of 15 of global QoL is the primary end-point. All patients who
fulfil the inclusion criteria and are offered allo-SCT with myeloablative condition are
invited to participate in the study about 1-3 months before commencing the treatment. The
patients have to give their written informed consent to participate in the study. The
patients enrolled in the study will be randomly assigned in blocks to the intervention- or
control group. The main end-point is three months after SCT. We will follow the patients
throughout the first year after SCT.
Nutrition intervention
The interventions start when the patients are arriving at the hospital for SCT and consist of
individualized nutrition supplement for each patient until discharge. The severity of nausea,
vomiting, diarrhea and mouth soreness will be a measure of the administration route of
nutrition (oral, PN and/or EN). The energy requirements will be calculated and the intake
monitored. The energy intake will continuously be adjusted to the energy requirements. The
patients who are able to achieve oral nutrition requirement will receive a therapeutic diet
using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will
be inserted during the first five days after transplantation. EN will be given when oral
intake discontinue, and an additional PN will be given if the estimated requirements by the
enteral route is lower than reference values. Dislodged tubes will promptly be replaced until
two times in the stomach. If the tube dislodge for more than two times, or voluminous
diarrhea appears, or the patients refuse the tube, the patients will be nourished by the PN
route only. The patients in the intervention group will receive dietary recommendation before
leaving the hospital. The patients in the control group will be nourished after established
routine, first by the oral route, later by the PN route. Naso-jejunal tube will not be
inserted and enteral nutrition will not be given.
Measurement of quality of life, mucositis and nutrition status
The patients score on the EORTC QLQ-C30 form at admission, i.e. 8 days prior to SCT, then
after 3 and 6 weeks and after 3, 6, 9 and 12 months. At the same time we will measure the
following several markers of nutritional status and parameters of hemostasis. We will also
record routine clinical parameters as well as anthropometry and body composition using
electrical bioimpedance. WHO Oral Toxicity Grading Scale will be used to measure oral
mucositis. In addition we will use the Patient-Generated Subjective Global Assessment
(PG-SGA).
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