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N/A N=119 Randomized Supportive Care

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

Effect of Individualized Nutrition on Quality of Life

Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Global Quality of Life Score — 58.8; 55.4 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Individualized Nutrition (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oslo University Hospital
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Global Quality of Life Score
58.8; 55.4
SECONDARY
Number of Underweight Participants
2; 4
SECONDARY
Number of Episodes With Fever
55; 59
SECONDARY
Duration Between Stem Cell Transplantation and Day of Engraftment.
15; 16
SECONDARY
Frequency of Acute Graft Versus Host Disease Grade 3-4
7; 13
SECONDARY
Number of Participants With Hospital Stay
37; 39
SECONDARY
Number of Participants With Pain, as Determined by EORTC QLQ C30
40; 48
SECONDARY
Number of Participants With Oral Mucositis Grade 3-4
42; 45

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.

Eligibility Criteria

Inclusion Criteria

  • acute lymphatic leukaemia, acute myeloid leukaemia, chronic myeloproliferative disease and chronic myelogenous leukaemia and other disorders accepted for allogeneic stem cell transplantation, following myeloablative conditioning

Exclusion Criteria

  • unable to give informed consent
  • unable to adhere to protocol due to reasons unrelated to the hematological condition
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01181076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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