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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01181076
• Collaborator: St. Petersburg State Pavlov Medical University (Other)
• Enrollment: 119
• Locations: 2
• Arms: 2
• Actual Duration (Months): 78.7
• Patients Per Site: 59.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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:

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Effect of Individualized Nutrition on Quality of Life	Dietary Supplement: Individualized Nutrition	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
• Actual Study Start Date: Aug 10, 2010
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Global Quality of Life Score [3 month after transplantation]

   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. The scores range from 0 to 100, higher scores mean better outcome.

Secondary Outcome Measures

1. Number of Underweight Participants [3 month after transplantation]

   Nutritional status will be assessed with anthropometry, biomarkers and bioimpedance. Here the number of underweight participants is reported.

2. Number of Episodes With Fever [Up to 8 months]

   Fever episodes

3. Duration Between Stem Cell Transplantation and Day of Engraftment. [Up to 1 months]

   Engraftment was judged by the number of days to neutrophils ≥0.2 × 109/l.

4. Frequency of Acute Graft Versus Host Disease Grade 3-4 [Up to 3 months]

5. Number of Participants With Hospital Stay [Up to 8 months]

6. Number of Participants With Pain, as Determined by EORTC QLQ C30 [3 months after transplantation]

   These scores (range 0-100) will be assessed with the EORTC QLQ C30 form. Higher scores means more pain.

7. Number of Participants With Oral Mucositis Grade 3-4 [Up to 3 months]

   Oral mucositis will be graded according to the World Health Organization Oral Toxicity Grading Scale, range 0-4 in scores, higher scores mean worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0027
2	Pavlov State Medical University of St. Petersburg	St. Petersburg		Russian Federation

Sponsors and Collaborators

• Oslo University Hospital
• St. Petersburg State Pavlov Medical University

Investigators

• Principal Investigator: Per O Iversen, MD, Oslo University Hospital

Study Documents (Full-Text)

• Study Protocol - Oct 23, 2009

More Information

Publications

None provided.

• Responsible Party: Kristin Joan Skaarud, Per Ole Iversen, MD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01181076
• Other Study ID Numbers: S-09136c
• First Posted: Aug 13, 2010
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Kristin Joan Skaarud, Per Ole Iversen, MD, Oslo University Hospital: Stem cell transplantation; Individualized Nutrition; Quality of life; Oral Mucositis; Adult

Study Results

Participant Flow

Pre-assignment Detail	As determined

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	59	60
COMPLETED	40	48
NOT COMPLETED	19	12

Baseline Characteristics

Arm/Group Title	Individualized Nutrition	Control Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	59	60	119
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	45	41	42
Sex: Female, Male (Count of Participants)
Female	20 33.9%	25 41.7%	45 37.8%
Male	39 66.1%	35 58.3%	74 62.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Norway	59 100%	60 100%	119 100%

Outcome Measures

1. Primary Outcome

Title	Global Quality of Life Score
Description	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. The scores range from 0 to 100, higher scores mean better outcome.
Time Frame	3 month after transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	40	48
Mean (Standard Deviation) [units on a scale]	58.8 (19.2)	55.4 (23.3)

2. Secondary Outcome

Title	Number of Underweight Participants
Description	Nutritional status will be assessed with anthropometry, biomarkers and bioimpedance. Here the number of underweight participants is reported.
Time Frame	3 month after transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Count of Participants [Participants]	2 3.4%	4 6.7%

3. Secondary Outcome

Title	Number of Episodes With Fever
Description	Fever episodes
Time Frame	Up to 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Number [Fever episodes]	55	59

4. Secondary Outcome

Title	Duration Between Stem Cell Transplantation and Day of Engraftment.
Description	Engraftment was judged by the number of days to neutrophils ≥0.2 × 109/l.
Time Frame	Up to 1 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Median (Full Range) [days]	15	16

5. Secondary Outcome

Title	Frequency of Acute Graft Versus Host Disease Grade 3-4
Time Frame	Up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Count of Participants [Participants]	7 11.9%	13 21.7%

6. Secondary Outcome

Title	Number of Participants With Hospital Stay
Time Frame	Up to 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Count of Participants [Participants]	37 62.7%	39 65%

7. Secondary Outcome

Title	Number of Participants With Pain, as Determined by EORTC QLQ C30
Description	These scores (range 0-100) will be assessed with the EORTC QLQ C30 form. Higher scores means more pain.
Time Frame	3 months after transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Count of Participants [Participants]	40 67.8%	48 80%

8. Secondary Outcome

Title	Number of Participants With Oral Mucositis Grade 3-4
Description	Oral mucositis will be graded according to the World Health Organization Oral Toxicity Grading Scale, range 0-4 in scores, higher scores mean worse outcome.
Time Frame	Up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Nutrition	Control Group
Arm/Group Description	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.	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.
Measure Participants	59	60
Number [participants]	42 71.2%	45 75%

Adverse Events

Time Frame	6 years
Arm/Group Title	Individualized Nutrition		Control Group
Arm/Group Description	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.		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.
All Cause Mortality
	Individualized Nutrition		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/59 (15.3%)		5/60 (8.3%)
Serious Adverse Events
	Individualized Nutrition		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Individualized Nutrition		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.