Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

NCT ID: NCT05045443

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-22
• Study Completion Date: 2024-01-04

Brief Summary

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

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

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DRUG

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

Standard of Care

Intervention Type: DIETARY_SUPPLEMENT

As per institution protocol for Standard of nutritional Care

Standard of nutritional care

Standard of nutritional support care

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: DIETARY_SUPPLEMENT

As per institution protocol for Standard of nutritional Care

Interventions

Curcumin

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

Intervention Type: DRUG

Standard of Care

As per institution protocol for Standard of nutritional Care

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Tumeric curcumin

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Soliman Elsayed Ebeid, MD

Professor of pediatrics Hematology Oncology and Bone Marrow Transplant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ihab Khairy, M.D

Role: STUDY_CHAIR

Faculty of Medicine Ain Shams University

Locations

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

Cairo, Non-US, Egypt

Countries

Egypt

Other Identifiers

FMASU MD 134/2021

Identifier Type: -

Identifier Source: org_study_id