Back to resultsSafety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia (CurcumPedALL)
Primary Purpose
Acute Lymphoblastic Leukemia, Pediatric
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Curcumin
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Lymphoblastic Leukemia, Pediatric focused on measuring Curcumin, Ain Shams University, Egypt, Acute Lymphoblastic Leukemia, Children
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).
Sites / Locations
- Pediatric Hematology Oncology and BMT Unit, Faculty of Medicine Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Curcumin
Standard of nutritional care
Arm 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
Standard of nutritional support care
Outcomes
Primary Outcome Measures
Determine the Safety of curcumin in pediatric patients with ALL.
Percentage of patients who developed adverse event
Secondary Outcome Measures
Full Information
NCT ID
NCT05045443
First Posted
September 7, 2021
Last Updated
September 16, 2021
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05045443
Brief Title
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Acronym
CurcumPedALL
Official Title
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric
Keywords
Curcumin, Ain Shams University, Egypt, Acute Lymphoblastic Leukemia, Children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Active Comparator
Arm 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
Arm Title
Standard of nutritional care
Arm Type
Placebo Comparator
Arm Description
Standard of nutritional support care
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Tumeric curcumin
Intervention Description
Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard of Care
Intervention Description
As per institution protocol for Standard of nutritional Care
Primary Outcome Measure Information:
Title
Determine the Safety of curcumin in pediatric patients with ALL.
Description
Percentage of patients who developed adverse event
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma S Ebeid, MD
Phone
+201095569596
Email
dr.fatma_ebeid@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Gamal, MD
Email
yasmingamal@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihab Khairy, M.D
Organizational Affiliation
Faculty of Medicine Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Pediatric Hematology Oncology and BMT Unit, Faculty of Medicine Ain Shams University
City
Cairo
State/Province
Non-US
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Soliman E Ebeid
Phone
01095569596
Email
dr.fatma_ebeid@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nihal Hussein
Email
nihal.hussien.ali@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
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