Clinical trial NCT01181076: Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Official title: Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Individualized Nutrition on Quality of Life
Keywords: Stem cell transplantation
Individualized Nutrition
Quality of life
Oral Mucositis
Adult
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Petersburg State Pavlov Medical University
First posted: 2010-08-13
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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

Primary outcomes:
measure: Global Quality of Life Score
timeFrame: 3 month after transplantation
Secondary outcomes:
measure: Number of Underweight Participants
timeFrame: 3 month after transplantation
measure: Number of Episodes With Fever
timeFrame: Up to 8 months
measure: Duration Between Stem Cell Transplantation and Day of Engraftment.
timeFrame: Up to 1 months
measure: Frequency of Acute Graft Versus Host Disease Grade 3-4
timeFrame: Up to 3 months
measure: Number of Participants With Hospital Stay
timeFrame: Up to 8 months
measure: Number of Participants With Pain, as Determined by EORTC QLQ C30
timeFrame: 3 months after transplantation
measure: Number of Participants With Oral Mucositis Grade 3-4
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: St. Petersburg
country: Russian Federation
facility: Pavlov State Medical University of St. Petersburg
Study officials:
affiliation: Oslo University Hospital
name: Per O Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skaarud KJ, Hov JR, Hansen SH, Kummen M, Valeur J, Seljeflot I, Bye A, Paulsen V, Lundin KEA, Troseid M, Tjonnfjord GE, Iversen PO. Mortality and microbial diversity after allogeneic hematopoietic stem cell transplantation: secondary analysis of a randomized nutritional intervention trial. Sci Rep. 2021 Jun 2;11(1):11593. doi: 10.1038/s41598-021-90976-z.