Trial Outcomes & Findings for Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life (NCT NCT01181076)

NCT ID: NCT01181076

Last Updated: 2020-01-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 119 participants
• Primary outcome timeframe: 3 month after transplantation
• Results posted on: 2020-01-22

Participant Flow

As determined

Participant milestones

Measure	Individualized Nutrition 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.	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.
Overall Study STARTED	59	60
Overall Study COMPLETED	40	48
Overall Study NOT COMPLETED	19	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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 n=119 Participants Total of all reporting groups
Age, Continuous	45 years n=59 Participants	41 years n=60 Participants	42 years n=119 Participants
Sex: Female, Male Female	20 Participants n=59 Participants	25 Participants n=60 Participants	45 Participants n=119 Participants
Sex: Female, Male Male	39 Participants n=59 Participants	35 Participants n=60 Participants	74 Participants n=119 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Norway	59 participants n=59 Participants	60 participants n=60 Participants	119 participants n=119 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Individualized Nutrition n=40 Participants 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.	Control Group n=48 Participants 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.
Global Quality of Life Score	58.8 units on a scale Standard Deviation 19.2	55.4 units on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: 3 month after transplantation

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

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Number of Underweight Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 8 months

Fever episodes

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Number of Episodes With Fever	55 Fever episodes	59 Fever episodes

SECONDARY outcome

Timeframe: Up to 1 months

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

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Duration Between Stem Cell Transplantation and Day of Engraftment.	15 days Interval 11.0 to 31.0	16 days Interval 10.0 to 30.0

SECONDARY outcome

Timeframe: Up to 3 months

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Frequency of Acute Graft Versus Host Disease Grade 3-4	7 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 8 months

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Number of Participants With Hospital Stay	37 Participants	39 Participants

SECONDARY outcome

Timeframe: 3 months after transplantation

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

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Number of Participants With Pain, as Determined by EORTC QLQ C30	40 Participants	48 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Individualized Nutrition n=59 Participants 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.	Control Group n=60 Participants 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.
Number of Participants With Oral Mucositis Grade 3-4	42 participants	45 participants

Adverse Events

Individualized Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristin Skaarud

Oslo University Hospital

Phone: 4723070000

Email: kskaarud@ous-hf.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place