Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Supportive Care
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2022

Detailed Description

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

Interventions

• Drug: Curcumin
  • Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement
• Dietary Supplement: Standard of Care
  • As per institution protocol for Standard of nutritional Care

Arms, Groups and Cohorts

• Active Comparator: Curcumin
  • 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
• Placebo Comparator: Standard of nutritional care
  • Standard of nutritional support care

Clinical Trial Outcome Measures

Primary Measures

• Determine the Safety of curcumin in pediatric patients with ALL.
  • Time Frame: 4 weeks
  • Percentage of patients who developed adverse event

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Ain Shams University
• Provider of Information About this Clinical Study
  • Principal Investigator: Fatma Soliman Elsayed Ebeid, Professor of pediatrics Hematology Oncology and Bone Marrow Transplant – Ain Shams University
• Overall Official(s)
  • Ihab Khairy, M.D, Study Chair, Faculty of Medicine Ain Shams University
• Overall Contact(s)
  • Fatma S Ebeid, MD, +201095569596, dr.fatma_ebeid@yahoo.com