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Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia

Primary Purpose

Acute Lymphocytic Leukemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphocytic Leukemia focused on measuring Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's cancer Hospital Egypt-57357

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NutriniDrink/Fortini group

control group

Arm Description

this group will receive 2 bottles of NutriniDrink/Fortini MF unflavoured daily (200 ml each) and standard dietary counselling for a period of 6 weeks.

this control group will only receive standard dietary counselling

Outcomes

Primary Outcome Measures

Study Parameters
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 Outcome Measures

Study Parameters
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 [%]

Full Information

First Posted
May 15, 2012
Last Updated
February 8, 2015
Sponsor
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT01600781
Brief Title
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
Official Title
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed on the Nutritional Status, Gut Microbiota and Quality of Life of Children With Acute Lymphocytic Leukemia: an Egyptian Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphocytic Leukemia
Keywords
Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NutriniDrink/Fortini group
Arm Type
Active Comparator
Arm Description
this group will receive 2 bottles of NutriniDrink/Fortini MF unflavoured daily (200 ml each) and standard dietary counselling for a period of 6 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
this control group will only receive standard dietary counselling
Intervention Type
Dietary Supplement
Intervention Name(s)
NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
Intervention Description
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
Primary Outcome Measure Information:
Title
Study Parameters
Description
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 [%]
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Study Parameters
Description
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 [%]
Time Frame
from day 1 to day 91 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa El-Hadad, PhD
Organizational Affiliation
Children's Cancer Hospita Egypt-57357
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's cancer Hospital Egypt-57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt

12. IPD Sharing Statement

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Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia

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