Trial record 12 of 1827 for:    Open Studies | "Nutrition"

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

This study is currently recruiting participants.
Verified April 2014 by Oslo University Hospital
Sponsor:
Collaborator:
Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01181076
First received: August 4, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 and develope less often oral mucositis grade 3-4 compared to a control group who receive routine nutrition support.

Sub-hypotheses:

Patients who receive individualized nutrition have:

i) better nutrition status ii) decreased length of hospital stay, less episodes with fever, earlier engraftment and less often acute graft versus host disease (GVHD) grade 3-4, and iii) 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.


Condition Intervention
Effect of Individualized Nutrition on Quality of Life
Dietary Supplement: Individualized Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individualized Nutrition Dietary Supplement: Individualized Nutrition
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.
No Intervention: Control group
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181076

Contacts
Contact: Kristin J Skaarud, MS +4797699148 kristin.joan.skaarud@oslo-universitetssykehus.no
Contact: Per Ole Iversen, MD +4741559532 p.o.iversen@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Kristin J Skaarud, PhD student    +4797699148    kristin.joan.skaarud@oslo-universitetssykehus.no   
Contact: Per O Iversen, Professor    +4741559532    p.o.iversen@medisin.uio.no   
Principal Investigator: Kristin J Skaarud, MSc         
Russian Federation
Pavlov State Medical University of St. Petersburg Recruiting
St. Petersburg, Russian Federation
Contact: Maxim Kucher, MD    +7921 9939902    doctorkucher@yandex.ru   
Contact: Boris Afanasyev, MD    +7921 9994639    bmt-director@spmu.rssi.ru   
Principal Investigator: Maxim Kucher, MD         
Sponsors and Collaborators
Oslo University Hospital
Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation
Investigators
Principal Investigator: Kristin J Skaarud, MS Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01181076     History of Changes
Other Study ID Numbers: S-09136c
Study First Received: August 4, 2010
Last Updated: April 10, 2014
Health Authority: Norway: Ethics Committee
Norway: Norwegian Social Science Data Services
Russia: Ethics Committee

Keywords provided by Oslo University Hospital:
Stem cell transplantation
Individualized Nutrition
Quality of life
Oral Mucositis
Adult

ClinicalTrials.gov processed this record on April 17, 2014