Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Mucositis consists of inflammation of the mucosal membrane and is a prominent cause of
 patient discomfort during cancer therapy. In children receiving chemotherapy, the incidence
 of oral mucositis is reported to be between 40%-70%. Curcumin, a commonly-used spice in India
 and Southeast Asia, was shown in animal models to prevent chemotherapy and radiotherapy
 induced mucositis. We hypothesize that curcumin may prevent oral mucosal injury and reduce
 the severity of oral mucositis in children receiving chemotherapy. Thus, the aim of this
 study is to determine whether in children undergoing doxorubicin-containing chemotherapy,
 does supplementation of curcumin, when compared to placebo, decrease oral mucositis both by
 objective (mucositis scales) and subjective (pain scale) measurements. Effective prevention
 and reduction of mucosal injury may significantly improve the care we provide to children
 undergoing therapy for cancer.
Children older than 5 years of age diagnosed with cancer and treated at the Pediatric
 Hematology/Oncology unit, Hadassah Medical Center will be eligible to the study. The study is
 designed as a cross-over study, wherein each patient serves as his or her own control, thus
 all included children should be scheduled to receive at least two identical curses of
 doxorubicin-containing chemotherapy in which the dose of doxorubicin is at least 60mg/m2 per
 course. The patients will be assigned to randomly receive curcumin or placebo in the 1st
 course, with the other regimen administered at the 2nd course. Curcumin will be given as
 fluid extract (1:1) at a dose of 10 drops, three times a day. Adolescents and young adults
 will receive the adult recommend dose, i.e. 30 drops, three times a day. Placebo will be
 given at the same dose. The patients will be taught to rinse the mouth with the medicine and
 than spit out. The therapy will be given from a day prior to the first day of the cycle for
 two weeks. A diary kept by the family will record each given dose. Possible side effects
 associated with the study drug, such as vomiting, nausea, rash, etc., will be recorded. No
 other adjunctive topical treatment will be used during the study. Adherence will be assessed
 through subject reports as well as by review of returned medications every cycle collected
 during the objective assessment site visits. Given the intent-to-treat analysis, all
 participants will be included irrespective of how much of the study medication was taken.The
 measurements of study outcome, i.e. OMAS score, WHO mucositis scale and visual analogue pain
 scale will be done on day 1,7,10,14,21 ± 1 of each chemotherapy cycle. The following data
 will be recorded in all cycles: duration of neutropenia, the need and length of
 hospitalization, use and dosage of opioid analgesia, need for total potential nutrition,
 blood culture positive infection and other mucositis related complications.
Inclusion Criteria:

 1. Children older than 5 years of age, adolescents and young adults diagnosed with cancer
 and treated at the Pediatric Hematology/Oncology unit, Hadassah Medical Center,

 2. A crossover study design is planed wherein each patient serves as his or her own
 control, thus all included children should be scheduled to receive at least two
 identical curses of doxorubicin-containing chemotherapy in which the dose of
 doxorubicin is at least 60mg/m2 per course,

 3. Patient's/ parent's informed consent.

 Exclusion Criteria:

 1. Patients treated with antiplatelet therapy or anticoagulation,

 2. Patients with biliary tract obstruction,

 3. Patients with preexisting oral disease, such as active oral infection, trauma to the
 oral mucosa or oral ulceration prior to chemotherapy,

 4. Patients receiving head and neck radiation,

 5. Developmentally unable to comply with curcumin mouth wash as judged by the parent or
 investigator.