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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


N/A
2 Years
12 Years
Open (Enrolling)
Both
Acute Lymphocytic Leukemia

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Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Study Parameters

Outcome 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 [%]

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

Alaa El-Hadad, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Cancer Hospita Egypt-57357

Authority:

Egypt: Institutional Review Board

Study ID:

CCHE-ALL001

NCT ID:

NCT01600781

Start Date:

December 2011

Completion Date:

March 2013

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Improve the nutritional status
  • QOL
  • children
  • enhance immune response
  • induction chemotherapy
  • fewer side effects
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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