CurcumPedALL: Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05045443

Collaborator

(none)

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia, Pediatric	Drug: Curcumin Dietary Supplement: Standard of Care	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Actual Study Start Date :

Aug 22, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Curcumin Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement Other Names: Tumeric curcumin Dietary Supplement: Standard of Care As per institution protocol for Standard of nutritional Care
Placebo Comparator: Standard of nutritional care Standard of nutritional support care	Dietary Supplement: Standard of Care As per institution protocol for Standard of nutritional Care

Arm

Intervention/Treatment

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

Drug: Curcumin

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

Other Names:

Tumeric curcumin

Dietary Supplement: Standard of Care

As per institution protocol for Standard of nutritional Care

Placebo Comparator: Standard of nutritional care

Standard of nutritional support care

Dietary Supplement: Standard of Care

As per institution protocol for Standard of nutritional Care

Outcome Measures

Primary Outcome Measures

Determine the Safety of curcumin in pediatric patients with ALL. [4 weeks]
Percentage of patients who developed adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).