Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Assessment of of the biological effects of curcumin on microbiota in children with acute lymphoblastic leukemia

Detailed Description
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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

Official Title
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Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia, Pediatric

Intervention / Treatment
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* Drug: Curcumin
* Dietary Supplement: Standard of Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcumin<br>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<br>* Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement<br>* Other names: Tumeric curcumin;Dietary Supplement: Standard of Care<br>* As per institution protocol for Standard of nutritional Care<br>|
| Placebo Comparator: Standard of nutritional care<br>Standard of nutritional support care | Dietary Supplement: Standard of Care<br>* As per institution protocol for Standard of nutritional Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Safety of curcumin in pediatric patients with ALL. | Percentage of patients who developed adverse event | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egypt, Curcumin, Ain Shams University, Acute Lymphoblastic Leukemia, Children