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Randomized Controlled Trial
. 2023 Apr 17;23(1):354.
doi: 10.1186/s12885-023-10730-8.

Efficacy of curcumin for amelioration of radiotherapy-induced oral mucositis: a preliminary randomized controlled clinical trial

Vahid Ramezani  1 , Shiva Ghadirian  2 , Masoud Shabani  3 , Mohammad Ali Boroumand  3 , Reza Daneshvar  3 , Fatemeh Saghafi  4
Affiliations
Randomized Controlled Trial

Efficacy of curcumin for amelioration of radiotherapy-induced oral mucositis: a preliminary randomized controlled clinical trial

Vahid Ramezani et al. BMC Cancer. .

Abstract

Background: Oral mucositis (OM) is one of the main problems in almost all patients undergoing head and neck radiotherapy (RT). Owning to the antioxidant and anti-inflammatory properties of curcumin, the effect of both oral and topical formulations of curcumin was assessed on radiation-induced OM (ROM) in this study.

Methods: The safety and efficacy of curcumin mouthwash 0.1% (w/v) and curcumin-nanocapsule were evaluated in ameliorating severity and pain/burning associated with OM during RT. The current randomized, placebo-controlled trial was conducted on 37 patients with head and neck cancers. Patients with grades 1 to 3 of ROM were randomized to receive one of the three interventions: curcumin mouthwash (0.1% w/v); Sinacurcumin soft gel containing 40 mg curcuminoids as nano-micelles (SinaCurcumin®40); or placebo mouthwash with a similar transparent appearance to curcumin mouthwash for 1 min three times daily during RT. Study evaluations were conducted at baseline and weekly thereafter for up to 3 weeks using the Numeric rating scale (NRS) and world health organization (WHO) scale.

Results: Among the 45 patients randomized, 37 (mean (SD) age of 53.36 (15.99) years; 14 [37.8%] women) completed the treatment according to the protocol. Patients treated with either oral or topical curcumin showed a significantly reduced severity and burning related to OM during the first 3 weeks after administration (P-Value < 0.001) as compared with the placebo. At study termination, more than 33% of subjects utilizing curcumin mouthwash and 15% of patients utilizing curcumin-nanocapsule remained ulcer free while all of the placebo-receiving subjects had OM. The reduction of NRS and WHO scale between curcumin groups was comparable without significant differences.

Conclusion: Both curcumin mouthwash and nanocapsule were effective, safe, and well-tolerated in the treatment of radiation-induced OM. Higher doses of curcumin and larger sample sizes can be used for further investigation in future studies.

Trial registration: https://irct.ir/ IRCT20190810044500N17 (13/08/2021).

Keywords: Curcumin; Neoplasms; Radiotherapy induced Mucositis.

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Conflict of interest statement

The authors declare that they have no competing interests regarding the publication of this paper.

Figures

Fig. 1
Fig. 1
Recruitment, Randomization, and Patient Flow to Treat Oral Mucositis
Fig. 2
Fig. 2
Variation of the primary and secondary outcomes over time; *P-value < 0.05 considered statistically significant
See this image and copyright information in PMC

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