Acute Lymphocytic Leukemia
Conditions
Keywords
Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects
Brief summary
This is a randomised, controlled, open-label intervention study. It is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may enhance their immune response. This could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.
Detailed description
Study objectives: Primary objective: To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the nutritional status of Egyptian children with acute lymphocytic leukemia (ALL) compared to standard dietary counseling. Secondary objective: To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the gut microbiota and quality of life (QoL) of Egyptian children with ALL compared to standard dietary counseling.
Interventions
DIETARY_SUPPLEMENTNutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
Sponsors
Children's Cancer Hospital Egypt 57357
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
• Newly diagnosed male and female paediatric ALL patients presenting in the study period. * Age should be above 2 years and children should be pre-pubertal. * Hospitalized for the entire (6 week) intervention period. * About to receive? induction chemotherapy. * Able to tolerate oral feeding. * Written informed consent from parents/guardian (and child, if applicable to local law).
Exclusion criteria
* ALL patients \< 2 years and those who show signs of puberty. * ALL patients who cannot tolerate oral feeding and/or are on parenteral nutrition. * ALL patients with a known history of cow's milk allergy/intolerance or galactosemia. * ALL patients requiring a fibre-free diet. * Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements. * Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Parameters | 42 days | Primary * Change in body weight between Baseline and Day 42 \[kg, weight-for-age z score, weight-for-height z-score\] * Percentage of children with body weight loss between Baseline and Day 42 \[%\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Parameters | from day 1 to day 91 of the study | * Stool microbiota at Baseline and at Day 42 \[proportion of Bifidobacteria, total stool culture\] * Quality of life at Baseline, at Day 42 and Day 91 \[PedsQL Cancer Module\] * Change in body weight between Baseline and Day 91 \[kg, weight-for-age z score, weight-for-height z-score\] * Percentage of children with body weight loss between Baseline and Day 91 \[%\] |
Countries
Egypt
Outcome results
None listed