Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale.

PURPOSE: The aim of this study was to utilise a novel oral assessment tool (the Oral Symptom Assessment Scale/OSAS) to investigate oral symptoms in a cohort of advanced cancer patients receiving specialist palliative care. METHODS: Participants were asked to complete the OSAS, which asks about the presence of 20 oral symptoms in the previous week (and, if present, about the frequency, the severity, and the amount of distress caused by the symptoms). Patients were also asked to complete the Memorial Symptom Assessment Scale - Short Form, and to rate their performance status. RESULTS: Two hundred fifty participants completed the study, and 244 (97.5%) participants reported at least one oral symptom on the OSAS. The median number of oral symptoms reported was five (range, 1 to 18), with dry mouth being the most common symptom (83.5% participants). The total number of oral symptoms was higher in younger participants (p = 0.012), female participants (p = 0.048), and those with a worse performance status (p < 0.001). No other oral symptoms were reported by more than two participants. Statistical analysis identified a number of potential oral symptom clusters. CONCLUSIONS: Oral symptoms (and related oral problems) are common in patients with advanced cancer, and are associated with significant morbidity in this group of patients. TRIAL REGISTRATION: CancerTrials.gov registry reference number: NCT04404920.

The Influence of Low Salivary Flow Rates on the Absorption of a Sublingual Fentanyl Citrate Formulation for Breakthrough Cancer Pain.

CONTEXT: Salivary gland hypofunction may affect the absorption of drugs through the oral mucosa, which in turn may affect their clinical efficacy (e.g., onset of action). OBJECTIVES: The aim of this study was to assess the pharmacokinetics of a sublingual fentanyl orally disintegrating tablet (Abstral, Prostrakan Inc.) in a group of cancer patients with salivary gland hypofunction. METHODS: Nine cancer patients with salivary gland hypofunction underwent a series of three pharmacokinetic studies with the sublingual fentanyl orally disintegrating tablet. In the first phase, the patients received no pretreatment; in the second phase, the patients were allowed to moisten the oral cavity before dosing; in the third phase, the patients were given pilocarpine hydrochloride (saliva stimulant) before dosing. Fentanyl concentrations were measured using a method of high-performance liquid chromatography with validated tandem mass spectrometric detection. RESULTS: The Tmax was longer, the Cmax was lower, the AUC0-30 lower, and the AUClast lower in the phase involving no pretreatment; the Tmax/Cmax/AUC0-30/AUClast were similar in the phase involving moistening of the oral cavity and the phase involving giving pilocarpine hydrochloride. CONCLUSION: The pharmacokinetics of the sublingual fentanyl orally disintegrating tablet appear to be negatively affected by the presence of salivary gland hypofunction, although the moistening of the oral cavity before dosing results in a pharmacokinetic profile similar to that seen with the giving of pilocarpine hydrochloride.

Breakthrough cancer pain: a comparison of surveys with European and Canadian patients.

INTRODUCTION: Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs spontaneously or in response to a trigger, despite stable and controlled background pain. Breakthrough pain often causes significant functional impairments for patients and can decrease quality of life. OBJECTIVE: The objective of the study was to determine differences between breakthrough cancer pain incidence and management in Canada and Europe. METHODS: Data collected from previous studies of breakthrough cancer pain in Canada and Europe was compared. A standard survey with identical inclusion/exclusion criteria was utilized for both patient populations. RESULTS: Both groups of patients had a similar number and duration of breakthrough pain episodes, and similar pain intensity and pain interference with their daily activities. European patients reported better analgesic efficacy and satisfaction with management, and a greater percentage of European patients were prescribed a transmucosal fentanyl formulation (19.1 vs 2.9 %). More European patients (55 %) than Canadian patients (32.5 %) took their rescue medication every time they had a breakthrough pain episode. CONCLUSIONS: Breakthrough cancer pain in both Canadian and European patients greatly impacts their daily living, and both groups of patients had similar experiences with breakthrough cancer pain. Currently, this pain is not adequately managed for many patients. The role for new analgesic treatments in management of breakthrough cancer pain needs further study.

Breakthrough cancer pain: the role of the nurse.

Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. Breakthrough pain is a heterogeneous condition, and so its management needs to be individualised. This paper describes the management of breakthrough pain and, specifically, the recently published guidelines of the European Oncology Nursing Society.

Breakthrough cancer pain: the current situation.

Breakthrough pain is common in patients with cancer. This paper describes the clinical features of breakthrough cancer pain (BTcP) and its impact on activities of daily living. It also describes the principles of BTcP management, highlighting some of the current issues and problems. A follow-up paper will describe current approaches to managing BTcP.

Breakthrough cancer pain: an observational study of 1000 European oncology patients.

CONTEXT: Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. OBJECTIVES: The aim of this study was to characterize breakthrough pain in a diverse population of cancer patients. METHODS: The study involved 1000 cancer patients from 13 European countries. Patients were screened for breakthrough pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their pain. RESULTS: Of the 1000 patients, 44% reported incident pain, 41.5% spontaneous pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident pain being five minutes (P < 0.001). The median duration of untreated episodes was 60 minutes, with the median for patients with incident pain being 45 minutes (P = 0.001). Eight hundred six patients stated that pain stopped them doing something, 66 that it sometimes stopped them doing something, and only 107 that it did not interfere with their activities. Patients with incident pain reported more interference with walking ability and normal work, whereas patients with spontaneous pain reported more interference with mood and sleep. As well, 65.5% of patients could identify an intervention that improved their pain (29.5%, pharmacological; 23%, nonpharmacological; 12%, combination). Regarding medications, 980 patients were receiving an opioid to treat their pain, although only 191 patients were receiving a transmucosal fentanyl product licensed for the treatment of breakthrough pain. CONCLUSION: Breakthrough cancer pain is an extremely heterogeneous condition.

Multi-centre European study of breakthrough cancer pain: pain characteristics and patient perceptions of current and potential management strategies.

This study involved 320 cancer patients from four Northern European countries. Patients with breakthrough pain were questioned about the characteristics of their pain, the current management of their pain, and the acceptability/utility of alternative routes of administration. The median number of episodes was 3/day. Forty-four percent patients reported incident-type pain, 39% spontaneous-type pain, and 17% a combination of these pains. The median duration was 60 min, and the median time to peak intensity was 15 min. Three percent patients reported "mild" pain, 37% "moderate" pain, and 60% "severe" pain. Ninety percent patients stated that the pain interfered with their daily activities. All patients were using opioids as rescue medication (mainly oral morphine/oxycodone), whilst 28% patients were using non-opioids, and 50% patients were using non-pharmacological interventions. Only 55% patients took rescue medication every time they experienced breakthrough pain. Sixty-five percent patients would definitely consider using an oral transmucosal product; patients from Denmark were less likely to answer positively, and a positive response was associated with previous use of the route for breakthrough pain. Seventy-three percent patients reported regular oral problems. Forty-two percent patients would definitely consider using an intranasal product, with 26% patients stating they would definitely not use such a preparation; patients from Denmark and Sweden were less likely to answer positively, and a positive response was associated with male gender, and previous use of the route. Forty-four percent patients reported regular nasal problems. Sixty percent patients would definitely consider using a subcutaneous product, and 44% patients would definitely consider using an intrapulmonary product.