Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Condition: Chemotherapy Induced Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mouth wash; Curcumol
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Mouth wash with chlorehexidin, three times a day; 5 ml in 50 ml water, mouthwash for 30 seconds, three times a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Doxorubicin; Mucositis; Prevention; Curcumin