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

Ain Shams University

Status and phase

Completed

Phase 2

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Treatments

Dietary Supplement: Standard of Care

Drug: Curcumin

Study type

Interventional

Funder types

Other

Identifiers

NCT05045443

FMASU MD 134/2021

Details and patient eligibility

About

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

Full 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

Enrollment

30 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No 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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups, including a placebo group

Curcumin

Active Comparator group

Description:

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

Treatment:

Drug: Curcumin

Dietary Supplement: Standard of Care

Standard of nutritional care

Placebo Comparator group

Description:

Standard of nutritional support care

Treatment:

Dietary Supplement: Standard of Care