Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Condition: Effect of Individualized Nutrition on Quality of Life
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Individualized Nutrition
Intervention type(s): Dietary Supplement
Intervention description(s): 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. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stem cell transplantation; Individualized Nutrition; Quality of life; Oral Mucositis; Adult