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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Children's Cancer Hospital Egypt 57357.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier:
NCT01600781
First received: May 15, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Acute Lymphocytic Leukemia
Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Children's Cancer Hospital Egypt 57357:

Primary Outcome Measures:
  • Study Parameters [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: from day 1 to day 91 of the study ] [ Designated as safety issue: Yes ]
    • 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 [%]


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NutriniDrink/Fortini group
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.
Dietary Supplement: NutriniDrink/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).
No Intervention: control group
this control group will only receive standard dietary counselling

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600781

Contacts
Contact: wafaa Rashed 202-01222260802 waffa.rashed@57357.com

Locations
Egypt
Children's cancer Hospital Egypt-57357 Recruiting
Cairo, Egypt, 11441
Contact: wafaa Rashed    202-01222260802    waffa.rashed@57357.com   
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
Principal Investigator: Alaa El-Hadad, PhD Children's Cancer Hospita Egypt-57357
  More Information

No publications provided

Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01600781     History of Changes
Other Study ID Numbers: CCHE-ALL001
Study First Received: May 15, 2012
Last Updated: May 16, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Children's Cancer Hospital Egypt 57357:
Improve the nutritional status
QOL
children
enhance immune response
induction chemotherapy
fewer side effects

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014