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OpenTrials
Completed

NCT Number: NCT05045443

Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Assessment of of the biological effects of curcumin on microbiota in children with acute lymphoblastic leukemia

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Key information

Conditions

Acute Lymphoblastic Leukemia, Pediatric Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Hematology Oncology and BMT Unit, Faculty of Medicine Ain Shams University

Cairo, Non-US, 11566, Egypt

About this study

Assessment of the safety of curcumin, which is the most active constituent of the ground rhizome of the Curcuma longa plant, in children with acute lymphoblastic leukemia patients (ALL) in maintenance phase of chemotherapy through the assessment of the any reported adverse event (AE). And assessment of the curcumin effect on health by eliminating intestinal microflora dysbiosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged from 1 year to 18 years Children with proven ALL diagnosed by bone marrow aspirate and immunephenotyping Patients in the maintenance phase week1

Exclusion criteria

Children with other maliganacies, Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including to sulfasalazine, warfarin, clopidogrel, aspirin, antacids, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil).

Treatment and study plan

curcumin

Drug

Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement

Other names: Tumeric curcumin

Standard of Care

Dietary Supplement

As per institution protocol for Standard of nutritional Care

Primary outcomes

  1. Determine the Safety of curcumin in pediatric patients with ALL.

    Time frame: 4 weeks

    Percentage of patients who developed adverse event

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: CurcumPedALL

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Sep 16, 2021
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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