Clinical Evidence

Topical Curcumin for the Prevention of Oral Mucositis in Pediatric Patients: Case series
Altern Ther Health Med. 2013; 19(3):21-24
Oral mucositis (OM), a common consequence of chemotherapy, is caused by inflammation and necrosis of oral mucosa. It has been reported in 40 to 80% of pediatric oncology patients. It results in pain, erythema and ulceration and thus makes swallowing difficult and often required opioid analgesia. Palifermin, a human recombinant keratinocyte growth factor (KGF), is the only agent currently approved by the FDA for the prevention of OM.

Curcumin is the major yellow pigment extracted from turmeric and has wide range of pharmacological activities such as anti-inflammatory, anticancer, antioxidant, wound healing, and antimicrobial effects. Animal model shows that Curcumin may prevent OM and before this study no clinical study has been reported.

Primary aim was to assess the tolerability of a Curcumin mouthwash and secondary aim was to describe oral mucositis in pediatric patients undergoing doxorubicin-containing chemotherapy.

Study Design:

Seven patients with a median age of 15.2 years who met the eligibility criteria (age ≥ 5 years, diagnosis of cancer and receiving doxorubicin-containing chemotherapy with at least 60 mg/m2 per course), were selected for placebo-controlled study. After the baseline evaluation all the participants were instructed to use 10 drops of Curcumall in a half glass (50 ml) of water twice daily (equivalent to 330mg/day), in addition to standard preventive oral care (chlorhexidine 0.2% mouthwash for 30 s twice per day), during treatment with high dose chemotherapy. Curcumall contains a tincture of Curcumin C3 95%, turmeric and ginger dissolved with glycerin and 0.4% alcohol. OM was assessed on days 0, 7, 10, 14 and 21 days. Primary outcome measure was oral adverse events related to curcumin use and secondary outcome measures were oral mucositis assessment scale (OMAS), world health organization (WHO) mucositis scale and visual analog pain scale (VAS). 

Results and Discussion:
  1. Due to low compliance of three patients (reason other than use of Curcumin mouth wash), out of the seven participants, they were excluded from the study. Only 4 participants had sufficient exposure to the topical Curcumin and therefore were included in the assessment of the OM. Also because of small sample size and lack of control group the study was considered as case study
  2. In four patients who fulfilled the criteria for compliance no oral or systemic adverse effect due to Curcumin mouthwash was observed
  3. In case of above 4 patients WHO, OMAS and VAS scores were lower than the severity of oral mucositis as mentioned in previous studies
  4. Four out of five patients developed OM, but the values were low reflecting a relatively mild case

This study was the first clinical trial of topical Curcumin for the prevention of OM. The results suggest that Curcumin is feasible as mouth wash, well-tolerated; its solution needs minimal preparation by the patient and is readily usable at home. It was also clear that despite participant’s high-dose cytotoxic protocol, the severity of OM in this study was relatively low. However, due to small sample size and lack of control group a large-scale controlled study in patients with severe mucositis is warranted to determine the efficacy of Curcumin therapy.