Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 May 1;45(5):183-189.
doi: 10.1097/COC.0000000000000905. Epub 2022 Apr 8.

A Chitosan-Coated Chamomile Microparticles Formulation to Prevent Radiodermatitis in Breast: A Double-blinded, Controlled, Randomized, Phase II Clinical Trial

Danielle C Garbuio  1 , Vanessa Dos Santos Ribeiro  2 , Ana C Hamamura  3 , Alexandre Faustino  3 , Luís Alexandre Pedro de Freitas  4 , Gustavo Viani  5 , Emília Campos de Carvalho  2
Affiliations
Clinical Trial

A Chitosan-Coated Chamomile Microparticles Formulation to Prevent Radiodermatitis in Breast: A Double-blinded, Controlled, Randomized, Phase II Clinical Trial

Danielle C Garbuio et al. Am J Clin Oncol. .

Abstract

Purpose: The aim was to evaluate the effect of a topical formulation containing chitosan-coated Chamomilla recutita (L.) rauschert microparticles regarding the incidence, grade, and days for the appearance of radiodermatitis (RD) in women with breast cancer.

Methods: A double-blinded, controlled, randomized, phase II clinical trial developed with women diagnosed with breast cancer who will receive radiation therapy. The participants were randomly divided into 2 groups: control and treatment. They were followed up until the end of the treatment or the appearance of grade III RD.

Results: Fifty-four women were included in the study. There is no significant difference between the groups in the incidence (88.9% vs. 88.9%, P=1.0) or time to develop any grade of RD (3 days of difference, P=0.300). A significant reduction was observed in the incidence (P=0.03) and in the time to appearance (7 d of difference, P=0.01) grade 2 or >RD. In the follow-up evaluation (15 d after the end of treatment), the Chamomile group presented a superior skin recovery than the control group (P=0.0343). High-intensity local symptoms as pain, and pruritus were significantly reduced in the Chamomile group.

Conclusions: Although no effect was observed with chamomile to reduce any grade of RD, it was effective to reduce grade 2 or >toxicity, to improve skin recovery and to diminish high-intensity local symptoms.

Trial registration: Brazilian Registry of Clinical Trials (ReBEC): RBR-9hnftg, April 29, 2019.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

References

    1. Olascoaga A, Vilar-Comte D, Poitevin-Chacón A, et al. Wound healing in radiated skin: pathophysiology and treatment options. Int Wound J. 2008;5:246–257.
    1. Denham JW, Hauer-Jensen M. The radiotherapeutic injury—a complex wound. Radiother Oncol. 2002;63:129–145.
    1. Devalia HL, Mansfield L. Radiotherapy and wound healing. Int Wound J. 2008;5:40–44.
    1. NHS Quality Improvement Scotland. Skincare of patients receiving radiotherapy. Best practice statement. NHS QIS, Scotland, 2010.
    1. Schneider F, Danski MTR, Vayego AS. Uso da Calendula officinalis na prevenção e tratamento de radiodermatite: ensaio clínico randomizado duplo cego. Rev Esc Enferm USP. 2015;49:221–228.

Publication types