Abstract
Context:
Gut microbiota may have a role in regulating the progress of cancer. Curcumin and its metabolites may have various effects on cancer treatments by eliminating intestinal microflora dysbiosis.
Objectives:
To assess the safety and efficacy of curcumin in children with acute lymphoblastic leukemia (ALL) and determine whether gut microbiota can be used to predict therapy-related complications.
Design:
Single-center, open-label prospective randomized controlled clinical trial.
Setting:
Pediatric Hematology Oncology Department, Ain Shams University Hospitals, Cairo, Egypt.
Methods:
All patients underwent detailed clinical assessment and anthropometric measurement. Nutritional assessment was performed using the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP), and nutrition risk were assigned based on 3 parameters: nutrition implication of the patient's medical diagnoses, recent nutrition intake, and anthropometrics. Complete blood count, total protein, and albumin were gathered. Fecal samples were collected to detect microbiota quantity.
Intervention:
A block-randomization scheme was generated by computer software; patients were randomized between curcumin plus the nutritional standard of care (SOC) and the nutritional SOC only, which consisted of a nutrition program through supplementation of a high-caloric, high-protein diet, tailored according to patients' age and sex for both groups. Curcumin 500 mg was supplemented per oral capsule twice daily for 1 month starting at week 1 of the maintenance phase of chemotherapy. Patients were followed up with once weekly during the curcumin supplementation to monitor compliance and adverse events. All assessments were performed at ALL diagnosis, at week 1 of maintenance phase of chemotherapy, and after 1 month of intervention.
Results:
Thirty pediatric patients with confirmed ALL were recruited from day of presentation and followed over a 12-month period. The majority of patients were under 10 years of age and presented mainly with fever at time of diagnosis. Their initial nutritional assessment showed STAMP scores of mainly 3 and 4. The curcumin showed a safety profile and was tolerated by most patients. The effects of curcumin on microbiota were studied through assessment of the proportions of Lactobacillus and Bifidobacterium in fecal samples, and the results are in the statistical analysis phase.
Conclusions:
This interim analysis showed a promising role of curcumin as a nutritional supplement in children with ALL.
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