N/A
N=119
Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Effect of Individualized Nutrition on Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT01181076 ↗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
| Outcome | Result | p-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
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.