Oral disorders (ODs) in palliative care (PC) are highly prevalent and significantly impact patients’ quality of life (QoL). Nevertheless, evidence-based management recommendations are lacking. Several natural products are safe, well-accepted, and effective for mucosal conditions.
Objective:
The study aimed to evaluate the efficacy of a propolis-based product combined with basic oral hygiene in preventing and treating ODs.
Design:
A prospective, open-label, single-center phase II study was performed. Adult patients in PC with cancer or noncancer diagnoses, who were conscious, able to swallow, with a life expectancy of more than one week, were recruited.
Results:
ODs’ improvement or maintenance of oral health was observed in 89.6% of cases. Severity of ODs significantly decreased (p < 0.001), along with reductions in oropharyngeal pain (p = 0.002) and dysgeusia (p < 0.001). Meal comfort, completion, and QoL improved; acceptability was excellent.
Conclusions:
The protocol was safe, well-accepted, and effective for ODs in adult patients in PC.
Study registration:
The study protocol was prospectively registered at ClinicalTrials.gov: NCT04911335.
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References
1.
FischerDJ, EpsteinJB, YaoY, WilkieDJ. Oral health conditions affect functional and social activities of terminally ill cancer patients. Support Care Cancer, 2014; 22(3):803–810.
2.
ChaushuG, BercoviciM, DoriS, et al.Salivary flow and its relation with oral symptoms in terminally ill patients. Cancer, 2000; 88(5):984–987.
3.
ColellaG, BoschettiCE, VitaglianoR, et al.Interventions for the prevention of oral mucositis in patients receiving cancer treatment: Evidence from randomised controlled trials. Curr Oncol, 2023; 30(1):967–980.
4.
MagnaniC, MastroianniC, GiannarelliD, et al.Oral hygiene care in patients with advanced disease: An essential measure to improve oral cavity conditions and symptom management. Am J Hosp Palliat Care, 2019; 36(9):815–819.
5.
DhaliwalJS, TalipT, RajamDT, et al.A systematic review of interventional studies on oral care of palliative patients. Ann Palliat Med, 2022; 11(9):2980–3000.
6.
SonisST. Treatment for oral mucositis-current options and an update of small molecules under development. Curr Treat Options Oncol, 2021; 22(3):25.
7.
EladS, YaromN, ZadikY, et al.The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies. CA Cancer J Clin, 2022; 72(1):57–77.
8.
SaarelaRK, HiltunenK, KautiainenH, et al.Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med, 2022; 13(1):213–220.
9.
HongCH, GueirosLA, FultonJS, et al.Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). Systematic review of basic oral care for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer, 2019; 27(10):3949–3967.
10.
GustafssonA, SkogsbergJ, RejnöÅ. Oral health plays second fiddle in palliative care: An interview study with registered nurses in home healthcare. BMC Palliat Care, 2021; 20(1):173.
11.
VenkatasaluMR, MurangZR, HusainiHABH, et al.Why oral palliative care takes a backseat? A national focus group study on experiences of palliative doctors, nurses and dentists. Nurs Open, 2020; 7(5):1330–1337.
12.
FerreiraAS, MacedoC, SilvaAM, et al.Natural products for the prevention and treatment of oral mucositis-a review. Int J Mol Sci, 2022; 23(8):4385.
13.
Al-MaweriSA, AlaizariN, AlanaziRH, et al.Efficacy of hyaluronic acid for recurrent aphthous stomatitis: A systematic review of clinical trials. Clin Oral Investig, 2021; 25(12):6561–6570.
14.
de Lima DantasJB, FreireTFC, SanchesACB, et al.Action of Matricaria recutita (chamomile) in the management of radiochemotherapy oral mucositis: A systematic review. Phytother Res, 2022; 36(3):1115–1125.
15.
LimaI, de Fátima Souto MaiorL, GueirosLAM, et al.Clinical applicability of natural products for prevention and treatment of oral mucositis: A systematic review and meta-analysis. Clin Oral Investig, 2021; 25(6):4115–4124.
16.
PasupuletiVR, SammugamL, RameshN, GanSH. Honey, propolis, and royal jelly: A comprehensive review of their biological actions and health benefits. Oxid Med Cell Longev, 2017; 2017:1259510.
17.
PireddaM, FacchinettiG, BiagioliV, et al.Propolis in the prevention of oral mucositis in breast cancer patients receiving adjuvant chemotherapy: A randomized controlled trial. Eur J Cancer Care, 2017; 26(6):e12757.
18.
PulitoC, CristaudoA, PortaCL, et al.Oral mucositis: The hidden side of cancer therapy. J Exp Clin Cancer Res, 2020; 39(1):210.
19.
YaromN, HovanA, BossiP, et al.Mucositis Study Group of the Multinational Association of Supportive Care in Cancer / International Society of Oral Oncology (MASCC/ISOO). Systematic review of natural and miscellaneous agents, for the management of oral mucositis in cancer patients and clinical practice guidelines—part 2: Honey, herbal compounds, saliva stimulants, probiotics, and miscellaneous agents. Support Care Cancer, 2020; 28(5):2457–2472.
20.
SimonR. Optimal two-stage designs for phase II clinical trials. Control Clin Trials, 1989; 10(1):1–10.
21.
von ElmE, AltmanDG, EggerM, et al.STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies. BMJ, 2007; 335(7624):806–808.
22.
ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice. J Postgrad Med, 2001; 47(3):199–203.
EilersJ, BergerAM, PetersenMC. Development, testing, and application of the oral assessment guide. Oncol Nurs Forum, 1988; 15(3):325–330.
25.
World Health Organization. Handbook for reporting results of cancer treatment. Geneva, Switzerland:. World Health Organization; 1979; 15–22.
26.
D’AngeloD, VelloneE, SalvatoriC, et al.Validity and reliability of the Italian version of the oral assessment guide. Prof Inferm, 2013; 66(2):117–124.
27.
National Cancer Institute—N.C.I. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 2009. National Institutes of Health.
28.
StiffPJ, ErderH, BensingerWI, et al.Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant, 2006; 37(4):393–401.
29.
IBM Corp. Relesead. 2019. IBM SPSS Statistics for Windows, Version 26. Armonk, NY: IBM Corp.
30.
WilbergP, HjermstadMJ, OttesenS, HerlofsonBB. Oral health is an important issue in end-of-life cancer care. Support Care Cancer, 2012; 20(12):3115–3122.
31.
SingerAE, GoebelJR, KimYS, et al.Populations and interventions for palliative and end-of-life care: A systematic review. J Palliat Med, 2016; 19(9):995–1008.
32.
BorghettiP, ImbresciaJ, VolpiG, et al.Prevention and management of acute esophageal toxicity during concomitant chemoradiotherapy for locally advanced lung cancer. Tumori J, 2022; 108(5):470–476.
33.
IppolitoE, FlorenoB, RinaldiCG, et al.Efficacy of a propolis-based Syrup (FARINGEL) in preventing radiation-induced esophagitis in locally advanced lung cancer. Chemotherapy, 2018; 63(2):76–82.
34.
DaviesA, BuchananA, ToddJ, et al.Oral symptoms in patients with advanced cancer: An observational study using a novel oral symptom assessment scale. Support Care Cancer, 2021; 29(8):4357–4364.
35.
GrandeGE, ToddCJ. Why are trials in palliative care so difficult. Palliat Med, 2000; 14(1):69–74.
36.
BlumD, InauenR, BinswangerJ, StrasserF. Barriers to research in palliative care: A systematic literature review. Progr Pall Care, 2015; 23(2):75–84.
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