Effect of Individualized Nutrition on Quality of LifeNASQNCT01181076
Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
A study testing Individualized Nutrition in people with Effect of Individualized Nutrition on Quality of Life, run by Oslo University Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect of Individualized Nutrition on Quality of Life
- What is being tested?
- Individualized Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Aug 2010to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to give informed consent
- unable to adhere to protocol due to reasons unrelated to the hematological condition
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Russia1 site
Pavlov State Medical University of St. Petersburg
Saint Petersburg
About this study
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.
Read more
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:
- 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.
Read the 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).
- Being tested
- Individualized Nutrition
- Keywords
- Stem cell transplantation, Individualized Nutrition, Quality of life, Oral Mucositis, Adult
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized NutritionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Nutrition | Experimental | Not described Receives: Dietary Supplement: Individualized Nutrition |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Quality of Life Score
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.
Measured: 3 month after transplantation
Secondary outcomes (7)
Number of Underweight Participants
Nutritional status will be assessed with anthropometry, biomarkers and bioimpedance. Here the number of underweight participants is reported.
Measured: 3 month after transplantation
Number of Episodes With Fever
Fever episodes
Measured: Up to 8 months
Duration Between Stem Cell Transplantation and Day of Engraftment.
Engraftment was judged by the number of days to neutrophils ≥0.2 × 109/l.
Measured: Up to 1 months
Frequency of Acute Graft Versus Host Disease Grade 3-4
Measured: Up to 3 months
Number of Participants With Hospital Stay
Measured: Up to 8 months
Number of Participants With Pain, as Determined by EORTC QLQ C30
These scores (range 0-100) will be assessed with the EORTC QLQ C30 form. Higher scores means more pain.
Measured: 3 months after transplantation
Number of Participants With Oral Mucositis Grade 3-4
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study start10 Aug 2010
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Effect of Individualized Nutrition on Quality of LifeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Petersburg State Pavlov Medical University
- Responsible party
- Principal investigator, Kristin Joan Skaarud, Oslo University Hospital
- Investigators
- Per O Iversen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181076
- Sponsor's protocol ID
- S-09136c
- Acronym
- NASQ
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2010
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gudmundstuen AM, Iversen PO, Pesonen M, Hjermstad MJ, Bye A, Tjonnfjord GE, Skaarud KJ. Comparing indirect calorimetry and predictive equations for energy expenditure - 1 year follow-up of adult hematopoietic stem cell transplanted recipients. Clin Nutr ESPEN. 2025 Dec;70:218-226. doi: 10.1016/j.clnesp.2025.09.027. Epub 2025 Sep 30.
PubMed 41038512Skaarud KJ, Gudmundstuen AM, Pesonen M, Hjermstad MJ, Iversen PO, Tjonnfjord GE. The role of fat-soluble vitamins for graft-versus host disease after myeloablative conditioning in allogeneic stem cell transplanted patients. Sci Rep. 2025 Jan 11;15(1):1675. doi: 10.1038/s41598-024-84805-2.
PubMed 39799129Skaarud 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.
PubMed 34078971
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
- ClinicalTrials.gov ID
- NCT01181076
- Acronym / sponsor ID
- NASQ / S-09136c
- Keywords
- Stem cell transplantation, Individualized Nutrition, Quality of life, Oral Mucositis, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Petersburg State Pavlov Medical University
- Study start
- 10 Aug 2010 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Nutrition | Experimental | Dietary Supplement: Individualized Nutrition |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- unable to give informed consent
- unable to adhere to protocol due to reasons unrelated to the hematological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized NutritionThe 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. | Dietary supplement | Individualized Nutrition |
Primary outcome
Global Quality of Life Score
Time frame: 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.
7 secondary outcomes
Number of Underweight Participants
Time frame: 3 month after transplantation
Number of Episodes With Fever
Time frame: Up to 8 months
Duration Between Stem Cell Transplantation and Day of Engraftment.
Time frame: Up to 1 months
Frequency of Acute Graft Versus Host Disease Grade 3-4
Time frame: Up to 3 months
Number of Participants With Hospital Stay
Time frame: Up to 8 months
Number of Participants With Pain, as Determined by EORTC QLQ C30
Time frame: 3 months after transplantation
Number of Participants With Oral Mucositis Grade 3-4
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41038512Gudmundstuen AM, Iversen PO, Pesonen M, Hjermstad MJ, Bye A, Tjonnfjord GE, Skaarud KJ. Comparing indirect calorimetry and predictive equations for energy expenditure - 1 year follow-up of adult hematopoietic stem cell transplanted recipients. Clin Nutr ESPEN. 2025 Dec;70:218-226. doi: 10.1016/j.clnesp.2025.09.027. Epub 2025 Sep 30.
- Derived from this study: PubMed 39799129Skaarud KJ, Gudmundstuen AM, Pesonen M, Hjermstad MJ, Iversen PO, Tjonnfjord GE. The role of fat-soluble vitamins for graft-versus host disease after myeloablative conditioning in allogeneic stem cell transplanted patients. Sci Rep. 2025 Jan 11;15(1):1675. doi: 10.1038/s41598-024-84805-2.
- Derived from this study: PubMed 34078971Skaarud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per O Iversen, MD principal investigator
Oslo University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nutrition in people with Effect of Individualized Nutrition on Quality of Life, run by Oslo University Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Quality of Life Score (time frame: 3 month after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.