Abstract 3181
Background
Oral pain, odynophagia and dysphagia, weight loss, dehydration, systemic infection, feeding support and hospitalization should be mentioned as the main determinated effect of oral mucositis (OM); this toxicity is often linked to chemo- or chemoradiotherapy. Oral Mucositis can reduce patients’compliance to cancer treatment and decreased their quality of life; it could be also reduce survival caused by discontinuation or dose reduction of anti-neoplasm therapy. The purpose of this study is to evaluate the impact of the three different products on OM outcomes of patients who received radio and chemotherapy in solid cancer.
Methods
From March to June 2018, 60 patients (pts) were randomized by Medical Oncology Unit of Rho - Milan. The pts were divided in 3 arms, belanced for tumor site and treatment, to receive the following medical devices: Gelx (oral spray), Episil (oral solution) and Gelclair (oral gel). Primary aim of the study was evaluation of OM onset, severity, reduction or remission and pain relief with the three devices in study. We analysed data with forms compiled by pts in 2 different steps: T0 (baseline) and follow-up (after 16 w); the clinicians evaluated OM grade in 2 steps: after 4 w and after 8 w. The pts’safety profile form included 10 items concerning difficulty of speaking, feeding, drinking and change of taste.
Results
The data analysis showed a significant difference among the 3 Groups. OM grade of Group 2 after 4 weeks is higher if compared with Group 1 and Group 3 After 4 weeks two cases of grade 4 mucositis has been achieved in Group 2, none in Group 1 and Group 3. Group GELX (Zinco gluconate included) demonstrated an overall better efficacy, in every analyzed safety profile items.
Conclusions
Even if prevention and treatment of OM are not yet clearly defined and recognized in the clinical practice, the study shows how the correct use of anti- mucositis product (accompanied by an appropriate hygienic and dietetic regimen) seems to be effective in the prevention of this pathology, which is the most frequent side effects on patients undergoing chemotherapy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5465 - Proof of concept clinical study by US-guided intratumor injection of VCN-01, an oncolytic adenovirus expressing hyaluronidase in patients with pancreatic cancer
Presenter: Manuel Hidalgo
Session: Poster Display session 1
Resources:
Abstract
2555 - A Phase 1a/b first-in-human, open-label, dose-escalation, safety, PK and PD study of TP-0903 in solid tumors
Presenter: John Sarantopoulos
Session: Poster Display session 1
Resources:
Abstract
3533 - First in human phase 1/2a study of PEN-866, a Heat Shock Protein 90 (HSP90) ligand – SN38 conjugate for patients with advanced solid tumors: Phase 1 results
Presenter: Johanna Bendell
Session: Poster Display session 1
Resources:
Abstract
4114 - A Phase I Open-Label, Non-Randomized Study of Recombinant Super-Compound Interferon (rSIFN-co) In Patients with Advanced Solid Tumors
Presenter: Amanda Seet
Session: Poster Display session 1
Resources:
Abstract
2537 - Evaluation of Pharmacodynamic (PD) Biomarkers in Advanced Cancer Patients Treated with Oxidative Phosphorylation (OXPHOS) Inhibitor, OPC-317 (OPC)
Presenter: Jie Qing Eu
Session: Poster Display session 1
Resources:
Abstract
5764 - Pharmacokinetic (PK) assessment of BT1718: A phase 1/2a study of BT1718, a first in class Bicycle Toxin Conjugate (BTC), in patients (pts) with advanced solid tumours
Presenter: Natalie Cook
Session: Poster Display session 1
Resources:
Abstract
2683 - A phase I open label dose escalation trial evaluating VT1021 in patients with advanced solid tumors.
Presenter: Wael Harb
Session: Poster Display session 1
Resources:
Abstract
3609 - Interim Results from Trial of SL-801, a Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors
Presenter: Judy Wang
Session: Poster Display session 1
Resources:
Abstract
3485 - Phase 1 Trial of Fruquintinib in Patients with Advanced Solid Tumors: Results of the Dose Escalation Phase
Presenter: Andrea Wang-Gillam
Session: Poster Display session 1
Resources:
Abstract
4085 - A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-601 in Patients with Advanced Solid Tumors
Presenter: Anthony Tolcher
Session: Poster Display session 1
Resources:
Abstract