Context. Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.Objectives. We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.Methods. A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]eItem 5) $ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.Results. Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P ¼ 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P ¼ 0.048). Clinically meaningful pain improvement ($30%) was reported by 44.1% (n ¼ 15) of patients in Group D vs. 18.2% (n ¼ 6) in Group P (P ¼ 0.02); 32.4% (n ¼ 11) vs. 3.0% (n ¼ 1) of patients in Groups D and P, respectively, reported pain reduction $ 50% (P ¼ 0.002).Conclusion. Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine. J Pain Symptom

The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.

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Introduction Although various phrases to communicate prognoses based on a certain concept have been proposed, no study has systematically investigated preferences of patients with cancer for actual phrases. We investigated whether phrases with a wider range and additional “hope for the best, and prepare for the worst” (hope/prepare) statement would be more preferable and explored variables associated with patients’ preferences. Materials and Methods In a cross‐sectional survey, 412 outpatients with cancer self‐assessed their preferences for 13 phrases conveying prognostic information (e.g., phrases with or without median, typical range, and/or best/worst cases, and those with or without a hope/prepare statement) on a 6‐point scale (1 = not at all preferable; 6 = very preferable). We evaluated demographic data and the Coping Inventory for Stressful Situations and conducted multivariate regression analysis. Results Regarding phrases with various ranges, the one including the median, typical range, and best/worst cases was more preferable (mean ± SD, 3.8 ± 1.3; 95% confidence interval [CI], 3.6–3.9) than the one with the median and typical range (3.4 ± 1.2; 3.3–3.6) or the one with only the median (3.2 ± 1.3; 3.1–3.3). Concerning the hope/prepare statement, the phrase including the median, typical range, uncertainty, and hope/prepare statement was more preferable (3.8 ± 1.4; 3.7–3.9) than the one without the statement (3.5 ± 1.2; 3.4–3.6). In multivariate analyses, task‐oriented coping was significantly correlated with preferences for phrases with explicit information. Conclusion Overall, phrases with a wider range and the hope/prepare statement were preferable to those without them. When patients with cancer ask about prognoses, especially those with task‐oriented coping, clinicians may provide explicit information with a wider range and the hope/prepare statement. Implications for Practice Discussing prognoses with patients with advanced cancer is among the most important conversations for clinicians. In this cross‐sectional survey to systematically investigate preferences of 412 patients with cancer for phrases conveying prognostic information, phrases with the median, typical range, and best/worst cases and those with the “hope for the best and prepare for the worst” (hope/prepare) statement were the most preferred. When patients with cancer ask about prognoses, clinicians may provide explicit information with a wider range and include the hope/prepare statement.

IntroductionCancer-related fatigue greatly influences quality of life in cancer patients; however, no specific treatments have been established for cancer-related fatigue, and at present, no medication has been approved in Japan. Systematic research using patient-reported outcome to examine symptoms, particularly fatigue, has not been conducted in palliative care settings in Japan. The objective was to evaluate fatigue, pain, and quality of life in cancer patients at the point of intervention by palliative care teams.Materials and MethodsPatients who were referred to palliative care teams at three institutions and met the inclusion criteria were invited to complete the Brief Fatigue Inventory, Brief Pain Inventory, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative.ResultsOf 183 patients recruited, the majority (85.8%) were diagnosed with recurrence or metastasis. The largest group (42.6%) comprised lung cancer patients, of whom 67.2% had an Eastern Cooperative Oncology Group Performance Status of 0–1. The mean value for global health status/quality of life was 41.4, and the highest mean European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative symptom item score was for pain (51.0). The mean global fatigue score was 4.1, and 9.8%, 30.6%, 38.7%, and 20.8% of patients’ fatigue severity was classified as none (score 0), mild (1–3), moderate (4–6), and severe (7–10), respectively.DiscussionCancer-related fatigue, considered to occur more frequently in cancer patients, was successfully assessed using patient-reported outcomes with the Brief Fatigue Inventory for the first time in Japan. Results suggested that fatigue is potentially as problematic as pain, which is the main reason for palliative care.

Background: Holistic multimodal interventions have not been established for cancer cachexia. The beliefs and perceptions of health care professionals (HCPs) based on their experiences influence the interventions. Objectives: HCPs' knowledge, perceptions, and practices in cancer cachexia management were evaluated. Design/Setting/Subjects/Measurements: A nationwide questionnaire survey was conducted that focused on the perspectives of HCPs on interventions in 451 designated cancer hospitals across Japan. Descriptive statistics were applied. Results: Among 2255 participants, 1320 responded (58.5%), and 1188 in 258 institutes were included in the analysis. The current international definition of cancer cachexia is not commonly known and recent clinical practice guidelines have not been widely adopted. More than 50% of participants considered ≥5% weight loss in six months and ECOG PS (Eastern Cooperative Oncology Group Performance Status) 2–4 to be cancer cachexia, whereas 50% answered that there was no relationship between life expectancy and cancer cachexia. Participants tended to consider it important to initiate nutritional and exercise interventions before cancer cachexia becomes apparent. The majority of participants recognized the importance of holistic multimodal interventions, particularly for the management of physical and psychological symptoms; however, only 20% reported that they educated patients and families. Furthermore, 33% of participants considered themselves to have provided patients and families with sufficient nutritional and exercise interventions and evidence-based information. Conclusion: The results reveal that HCPs are not regularly providing education and emotional support to patients and families suffering from cancer cachexia. The results also show the need for education for HCPs to enhance implementation of holistic multimodal interventions for cancer cachexia.

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ObjectiveThis post hoc, pooled, subgroup analysis of two randomised studies evaluated baseline characteristics that may influence the efficacy and safety of naldemedine in patients with opioid-induced constipation (OIC) and cancer.MethodsData for patients who received 0.2 mg naldemedine or placebo were pooled from randomised, placebo-controlled, phase IIb and phase III studies. Proportions of spontaneous bowel movement (SBM) responders and patients with diarrhoea were assessed for each treatment group. For the patient subgroups with or without possible blood–brain barrier (BBB) disruptions, changes in Numerical Rating Scale (NRS) and Clinical Opioid Withdrawal Scale (COWS) scores were assessed.ResultsA total of 307 patients were included in this analysis (naldemedine: n=155; placebo: n=152). The pooled proportion of SBM responders was 73.5% with naldemedine versus 35.5% with placebo. There was a significant increase in the proportion of SBM responders with naldemedine versus placebo (38.0% (95% CI 27.6% to 48.4%); p<0.0001). Greater proportions of SBM responders and patients who experienced diarrhoea were observed with naldemedine versus placebo in all subgroups. Changes from baseline in NRS and COWS scores were similar with naldemedine or placebo in patients with or without brain metastases.ConclusionsAlthough not powered to detect statistically significant differences in treatment effect among subgroups, this study demonstrated that naldemedine appeared to benefit patients with OIC and cancer, irrespective of baseline characteristics, and did not seem to affect analgesia or withdrawal–even in patients with potential BBB disruptions. Baseline characteristics did not appear to affect the incidence of diarrhoea in patients who received naldemedine.Trial registration numbersJapicCTI-111510 and JapicCTI-132340.