Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life (NASQ)

• Global quality of life score [ Time Frame: 3 month after transplantation ] [ Designated as safety issue: No ]
  A score for measurement of global quality of life will be obtained from the European Organisation for Research and Treatment of Cancer, form EORTC QLQ-C30.
  
  
• Number of days with oral mucositis grade 3-4 [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  Oral mucositis will be graded according to the World Health Organization Oral Toxicity Grading Scale.
  
  

• Nutrition status [ Time Frame: 3 month after transplantation ] [ Designated as safety issue: No ]
  Nutritional status will be assessed with anthropometry, biomarkers and bioimpedance.
  
  
• Number of episodes with fever [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  
• Duration between stem cell transplantation and day of engraftment. [ Time Frame: Up to 1 months ] [ Designated as safety issue: No ]
  
• Frequency of acute graft versus host disease grade 3-4 [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  
• Length of hospital stay [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  
• Quality of life scores for physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
  These scores will be assessed with the EORTC QLQ C30 form.
  
  

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).