Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

NCT05045443 | Completed Phase 2 DMC

• 1 other identifier: FMASU MD 134/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Curcumin; Ain Shams University; Egypt; Acute Lymphoblastic Leukemia; Children

Outcome Measures

Primary Outcomes (1)

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

  Percentage of patients who developed adverse event

  4 weeks

Study Arms (2)

Curcumin

ACTIVE COMPARATOR

Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement (composed of Tumeric (curcuma longa)root 450mg and Tumeric extract (curcuma longa )root 50mg ) standardized to contain 95%curcuminoids, it will given twice daily for 1 month starting at week 1 of maintenance phase of chemotherapy (Time 1) . It is preferably to be taken with meals but may be opened and prepared as a tea

Drug: Curcumin; Dietary Supplement: Standard of Care

Standard of nutritional care

PLACEBO COMPARATOR

Standard of nutritional support care

Dietary Supplement: Standard of Care

Interventions

Curcumin DRUG

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

Also known as: Tumeric curcumin

Curcumin

Standard of Care DIETARY_SUPPLEMENT

As per institution protocol for Standard of nutritional Care

Curcumin; Standard of nutritional care

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Non-US, 11566, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Curcumin; Standard of Care

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ihab Khairy, M.D

  Faculty of Medicine Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of pediatrics Hematology Oncology and Bone Marrow Transplant

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: August 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 4, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)