Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy
The aim of the current analysis was to evaluate the effectiveness and tolerability of rapid onset opioid in a cohort of head and neck cancer (HNC) patients affected by painful mucositis influencing swallowing function during RT ± ChT with definitive or adjuvant intent.
A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals. The period of observation has been 90 days starting from the beginning of RT ± ChT.
Forty HNC patients with incidental BTP due to painful mucositis treated with FPNS were analyzed. The mean NRS of untreated episodes of BTP was 5.73 ± 1.54 decreasing to 2.25 ± 2.45 with FPNS (median dose 100 mcg). During the pain treatment, the number of meals increased from 2.08 ± 0.35 to 2.868 ± 0.4 (p = 0.000), and the BMI remained stable (from 25.086 ± 3.292 to 25.034 ± 3.090; p = 0.448). The 94.9% of patients was satisfied or very satisfied for the rapidity of the effect, and 97.4% for the easiness and convenience in the use.
FPNS showed an acceptable safety activity profile in predictable BTP due to painful mucositis in HNC patients during RT ± ChT. FPNS was also effective in reducing the mucositis sequelae and allowing the completion of RT scheduled scheme. Moreover, patients declared satisfaction in terms of ease of use.
KeywordsFentanyl nasal spray Mucositis Pain Head and neck cancer Radiotherapy
We wish to thank Stella Baffini for her valuable contribution.
Compliance with ethical standards
Conflict of interest
We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no financial support for this work that could have influenced its outcome.
- 2.Elting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, et al. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008;113:2704–13.CrossRefPubMedGoogle Scholar
- 4.Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003;66:253–62.CrossRefPubMedGoogle Scholar
- 5.Mazzola R, Ricchetti F, Fiorentino A, Di Paola G, Fersino S, Giaj Levra N, et al. Cachexia induces head and neck changes in locally advanced oropharyngeal carcinoma during definitive cisplatin and image-guided volumetric-modulated arc radiation therapy. Eur J Clin Nutr. 2016;70(6):738–42.CrossRefPubMedGoogle Scholar
- 16.Ripamonti CI, Santini D, Maranzano E, Berti M, Roila F, ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol 2012;23(Suppl 7):vii139–54.Google Scholar
- 17.Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, et al., European Association for Palliative Care EAPC. Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol 2012; 13(2):e58–68.Google Scholar
- 18.Fallon M, Reale C, Davies A, Lux AE, Kumar K, Stachowiak A, et al. Efficacy and safety of fentanyl pectin nasal spray compared with immediate-release morphine sulfate tablets in the treatment of breakthrough cancer pain: a multicenter, randomized, controlled, double-blind, double-dummy multiple-crossover study. J Support Oncol. 2011;9:224–31.CrossRefPubMedGoogle Scholar
- 19.Davies A, Sitte T, Elsner F, Reale C, Espinosa J, Brooks D, et al. Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. J Pain Symptom Manag. 2011;41(2):358–66.CrossRefGoogle Scholar
- 20.Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, et al. Perspectives on cancer therapy-induced. Mucosal injury pathogenesis, measurement, epidemiology, and consequences for patients. Cancer Supplement 2004;100(9):1995–2025.Google Scholar
- 21.Peterson DE, Bensadoun RJ, Roila F. Management of oral and gastrointestinal mucositis: ESMO clinical practice guidelines. Ann Oncol. 2011;22 (Supplement 6):vi78–vi84.Google Scholar
- 24.Bhide AS, Gulliford S, Fowler J, Rosenfelder N, Newbold K, Harrington KJ, et al. Characteristics of response of oral and pharyngeal mucosa in patients receiving chemo-IMRT for head andneck cancer using hypofractionated accelerated radiotherapy. Radiother Oncol. 2010;97:86–91.CrossRefPubMedGoogle Scholar
- 25.Mazzola R, Ricchetti F, Fiorentino A, Fersino S, Giaj Levra N, Naccarato S, et al. Dose-volume-related dysphagia after constrictor muscles definition in head and neck cancer intensity-modulated radiation treatment. Br J Radiol. 1044;2014(87):20140543.Google Scholar
- 26.Mazzola R, Ricchetti F, Fersino S, Fiorentino A, Giaj Levra N, Di Paola G, et al. Predictors of mucositis in oropharyngeal and oral cavity cancer in patients treated with volumetric modulated radiation treatment: a dose-volume analysis. Head Neck. 2016;38(Suppl 1):E815–9.CrossRefPubMedGoogle Scholar
- 29.Gayoso LO, Rijo GJ, Sánchez ÁR, De Celis RP, Albiach CF, Moreno AJC, et al. Radiotherapy induced breakthrough cancer pain: Is it possible to optimize its treatment? Revista de la Sociedad Espanola del Dolor 2015;22:4 (159–164).Google Scholar