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To evaluate the change over time of vision-related quality of life (QoL) and glaucoma symptoms in a population of newly-diagnosed primary open angle glaucoma (POAG) patients. Multicenter, prospective study. Consecutive newly-diagnosed POAG patients were enrolled and followed-up for one year. Follow-up visits were scheduled at 6 and 12 months from baseline. At each visit, vision-related QoL and glaucoma-related symptoms were assessed by the means of the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the Glaucoma Symptom Scale (GSS), respectively. Trends over time for NEI-VFQ-25 and GSS scores were evaluated with longitudinal linear mixed models. One-hundred seventy-eight patients were included in the analysis. At baseline, early to moderate glaucoma stages were associated with higher scores for most GSS and NEI-VFQ-25 items, while lower best-corrected visual acuity was associated with lower scores for 4 of the 12 NEI-VFQ-25 items. During the follow-up, all the GSS scores, the NEI-VFQ-25 total score, and 7 of the 12 NEI-VFQ-25 scores significantly improved (p

Objectives: A combination of chemotherapy and radiotherapy is employed in the curative and postoperative treatment of locally advanced head and neck cancers (HNC). Integrated chemoradiation (CRT) treatments result in a non-negligible rate of severe toxic effects. Treatment-related death (TRD) is a crucial topic for physicians involved in the curative treatment of HNC. This meta-analysis aimed to better address TRD in locally advanced HNC patients treated with CRT through available and relevant literature. Methods: We performed a systematic review of the literature according to the PRISMA statement. The studies fulfilling these criteria included the following: concurrent or alternating CRT; both radical and postoperative settings; published from 2000 to 2020; involving 100+ patients; and available toxicity data. TRD was defined as death occurring from CRT start until a month from the end of CRT. Potential TRD predictors were evaluated. Results: In all, 65 studies were retrieved, with a total of 235 TRDs reported accounting for an overall risk rate of 1.4%. At meta-regression analysis, T stage and neutropenia grade >3 were potential predictors of higher TRD risk, both in univariate and multivariate analyses. Considering only the studies reporting at least one event, laryngeal/hypopharyngeal, oral cavity subsites and renal failure were significant predictors for TRD. The oropharyngeal subsite was protective in both analyses. None of the predictors proved to be independently correlated with TRD at multivariable analysis. Conclusion: CRT in HNC resulted in 1.4% of TRDs. TRD rate reduction may imply better patient selection and more intensive supportive care programs. [ABSTRACT FROM AUTHOR]

Aims and objectives: To assess the effectiveness of a specific home care nursing programme in addition to standard care in patients (pts) receiving oral anticancer treatments. Background: Oral anticancer therapy present challenges for pts since treatment is a home‐based therapy. This study evaluates the potentiality of a home care nursing programme in decreasing hospital accesses for not severe toxicity. Methods: This is an open‐label, multicentre, randomised trial including pts who were receiving an anticancer oral drug. The study complies with the CONSORT checklist published in 2010. Concomitant use of radiation therapy, intravenous or metronomic therapies, or the intake of previous oral drugs was not allowed. Pts were randomly assigned to home care nursing programme (A) or standard care (B). In arm A, dedicated nurses provided information to pts, a daily record on which pts would take note of drugs and dosages and a telephone monitoring during the first two cycles of therapy. The primary outcome was the reduction in improper hospital accesses for grade 1–2 toxicity according to CTCAE v4.0. Results: Out of 432 randomised pts, 378 were analysed (184 pts in arm A and 194 in arm B). Hospital accesses were observed in 41 pts in arm A and in 42 pts in arm B (22.3% vs. 21.6%, respectively). No difference was detected in proportion of improper accesses between arm A and arm B (29.3% vs. 23.8%, respectively). Conclusions: Our experience failed to support the role of a specific home care nursing programme for pts taking oral chemotherapy. An improved attention to specific educational practice and information offered to pts can explain these results. Relevance to clinical practice: Our results underline the role of nurse educational practice and information offered to patients. A careful nurse information of patients about drugs is essential to reduce toxicities avoiding the opportunity of a specific home monitoring. [ABSTRACT FROM AUTHOR]

Introduction: The CoQun® study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun®, an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE), in patients affected by primary open-angle glaucoma (POAG). Pre-clinical studies and small non-controlled clinical trials have previously shown a potential role of CoQ10 and VitE in glaucoma neuroprotection, both in vitro and in vivo.Methods: Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment. Inclusion criteria will be visual field (VF) mean deviation between - 4 and - 10 dB and VF Pattern Standard Deviation between 4 and 10 dB. Eligible patients will be randomized to receive CoQun® (Arm A) or placebo (Arm B), in addition to PGA monotherapy.Planned Outcomes: Primary outcome will be time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression. A total of 612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided). For study power calculation, 10% non-evaluable patients are assumed. This is the first study investigating, in a randomized, double-blind and controlled fashion, the neuroprotective effects of CoQ10 and VitE in POAG patients.Trial Registration: ClinicalTrials.gov identifier, NCT03611530. [ABSTRACT FROM AUTHOR]

Background: Oxycodone‐naloxone (OXN) aims to reduce opioid‐related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. Pain intensity, changes of therapy, and adverse drug reactions were recorded at each visit. The primary efficacy endpoint was the proportion of responders (≥30% reduction of pain intensity from baseline to final) and final average pain score ≤ 4 on a scale of 0 to 10. Results: Average and worst pain intensity and breakthrough pain (BTP) prevalence decreased over time, and 81.3% of patients were responders. The starting daily dose of OXN was raised from 25.1 ± 13.0 mg to 44.1 ± 29.9 mg, and dose escalation > 5%/day was observed in 19.4% of patients; 40.8% to 46.2% and 11.0% to 17.0% experienced any constipation and a severe grade of constipation during the follow‐up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785. [ABSTRACT FROM AUTHOR]