Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 1

5683 - Prevention of chemoradiation-related mucositis in patients with head and neck cancer using dexamethasone-based mouthwash: A phase II randomized double-blind, placebo-controlled study

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Supportive Care and Symptom Management

Tumour Site

Presenters

Naiyarat Prasongsook

Citation

Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265

Authors

N. Prasongsook1, P. Kaewvatee2, C. Ajalanond3, S. Srichamchan2, K. Seetalarom2

Author affiliations

  • 1 Medical Oncology, Phramongkutklao Hospital, 40110 - Bangkok/TH
  • 2 Medical Oncology, Phramongkutklao Hospital, 10400 - Bangkok/TH
  • 3 Pharmacy, Phramongkutklao Hospital, 10400 - Bangkok/TH

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5683

Background

Oral mucositis (OM) is the most common adverse event in patients with head and neck cancer (HNC) who are treated with chemoradiotherapy (CRT). Normal saline/ or benzydamine hydrochloride oral rinse might reduce OM incidence and severity. However, the need for interruption of CRT may occurred. A phase II study of steroid solution for stomatitis prophylaxis has been reported in patients with advanced stage breast cancer who was treated with mTOR inhibitor. We aimed to assess the efficacy of dexamethasone-based mouthwash for prevention of oral mucositis (OM) in HNC patients who were receiving with CRT.

Methods

In this phase II, double-blind, placebo-controlled study, we enrolled 27 patients with HNC who were treated with CRT. Those patients were randomized (1:1) to received dexamethasone-based mouthwash (0.5 mg in 10 ml of normal saline solution) (n = 14) versus placebo plus normal saline solution (n = 13) at a day before starting in CRT schedule (rinse for 2 min and spit, four time daily for 10 weeks). The primary endpoint was incidence- and severity of OM, which focused on pain score by 10 weeks evaluated in the full analysis.

Results

There was statistically significant difference in the incidence of WHO grade 2 OM at 3 weeks after randomization (23.1% placebo group vs 0% in dexamethasone-based solution group, p-value=0.003). At 6 weeks, 84.6% of patients in placebo group developed grade 2 or higher OM, and only 7.1% in dexamethasone-based solution group (p-value <0.001). Furthermore, pain score in patient with dexamethasone-based solution group was lower than placebo group significantly at 3 weeks until complete treatment.

Conclusions

Dexamethasone-based solution mouthwash significantly reduced the incidence and severity of oral mucositis in head and neck cancer patients receiving chemoradiotherapy, and could be a new standard of care for prevention of oral mucositis from chemoradiation treatment.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Phramongkutklao College of Medicine/ Department of Medicine, Phramongkutklao Hospital.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.