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

NCT01181076 | Completed Results DMC

• 1 other identifier: S-09136c
• Study Type: interventional
• Target: 119
• Locations: 2 countries
• Sites: 2

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.

Conditions

Effect of Individualized Nutrition on Quality of Life

Keywords

Stem cell transplantation; Individualized Nutrition; Quality of life; Oral Mucositis; Adult

Outcome Measures

Primary Outcomes (1)

• 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.

  3 month after transplantation

Secondary Outcomes (7)

• Number of Underweight Participants

  3 month after transplantation

• Number of Episodes With Fever

  Up to 8 months

• Duration Between Stem Cell Transplantation and Day of Engraftment.

  Up to 1 months

• Frequency of Acute Graft Versus Host Disease Grade 3-4

  Up to 3 months

• Number of Participants With Hospital Stay

  Up to 8 months

Study Arms (2)

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.

Interventions

Individualized Nutrition DIETARY_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.

Individualized Nutrition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to give informed consent
• unable to adhere to protocol due to reasons unrelated to the hematological condition

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Petersburg State Pavlov Medical University: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, 0027, Norway

Location

Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

Location

Related Publications (3)

• 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.

  PMID: 41038512 DERIVED

• Skaarud 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.

  PMID: 39799129 DERIVED

• 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.

  PMID: 34078971 DERIVED

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Kristin Skaarud
• Organization: Oslo University Hospital

kskaarud@ous-hf.no

4723070000

Study Officials

• Per O Iversen, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Per Ole Iversen, MD

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 13, 2010
• Study Start: August 10, 2010
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Locations

RU (1); NO (1)