Open-label, randomized, multicenter, phase IV trial comparing parenteral nutrition using multi-chamber bags (Eurotubes) versus traditional 2/3-chamber bags in subjects with metastatic or locally advanced inoperable cancer requiring parenteral nutrition: The PEKANNUSS trial of the AIO.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS7086-TPS7086
Author(s):  
Georg Martin Haag ◽  
Ralf-Dieter Hofheinz ◽  
Jann Arends ◽  
Thorsten Oliver Goetze ◽  
Ingeborg Roetzer ◽  
...  
Keyword(s):  
Food Intake ◽  
Parenteral Nutrition ◽  
Care Service ◽  
Locally Advanced ◽  
Self Administration ◽  
Open Label ◽  
Increased Risk ◽  
Low Glucose ◽  
Phase Iv ◽  
At Home

TPS7086 Background: Approximately 50% of all cancer subjects suffer from cancer anorexia-cachexia syndrome accompanied by an inadequate food intake and predicting mortality, poor therapeutic response, diminished functional capacity, and reduced QoL. Especially in the advanced stages, parenteral nutrition (PN) is often required and accompanied by an increased risk of blood stream infections associated with increased mortality and other serious medical conditions such as sepsis. Furthermore, the switch from oral food intake to PN changes the patient’s everyday life leading to reduced autonomy and flexibility (e.g. due to dependency on home nursing services). This study aims at evaluating the incidence of catheter-related infections (CRI) and the frequency of self-administered parenteral nutrition at home (HPN) in patients receiving standard PN via A) traditional two- or three-chamber bags (often requiring addition of vitamins and/or medications by home care service) or B). the multi-chamber bags Eurotubes (minimizing additional supplements and enabling self-administration by patients at home). In addition, one group of patients will receive low glucose HPN via Eurotubes to investigate a possible benefit on clinical outcome. Methods: This is an open-label, randomized, multicenter, investigator-initiated, phase IV trial. Overall, 350 patients with inoperable metastatic or locally advanced solid tumors who have an indication for parenteral nutrition will be enrolled. Patients will be randomized 1:1:1 ratio to Arm A (Standard PN using Eurotubes) or Arm B (Standard PN using 2/3-chamber bags), or to Arm A-1 (low glucose using Eurotubes). Patients will be assessed (physical exam, ECOG, weight, QoL, lab tests, AEs, HPN documentation) every 4 weeks during the 12 months HPN treatment period. Co-primary endpoints are incidence of CRI and patient autonomy (rate of self-administered PN at home). Secondary endpoints comprise weight change, change in albumin and CRP levels, overall survival, QoL, and safety. Recruitment has just started; first patient in was on February 5th, 2020. Clinical trial information: NCT04105777 .

scholarly journals Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting: protocol for a phase IV, single-arm, open-label trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e020242 ◽  
Author(s):  
Emilio Gil ◽  
Fernando Garcia- Alonso ◽  
Anca Boldeanu ◽  
Thaïs Baleeiro Teixeira
Keyword(s):  
Hospital Setting ◽  
Antipsychotic Agent ◽  
Beta Agonist ◽  
Self Administration ◽  
Open Label ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Healthcare Facilities ◽  
Moderate Agitation ◽  
Phase Iv

IntroductionThere is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting.Methods and analysisThis phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway, Romania and Austria. The aim is to include approximately 500 patients with schizophrenia or bipolar disorder who previously received and responded well to inhaled loxapine in the hospital setting. Eligible patients will be followed up for 6 months from baseline. They will be given a 10 mg dose of inhaled loxapine to self-administer outside the hospital setting to treat an agitation episode, should one occur. Patients will also be given a short-acting beta-agonist bronchodilator for treatment of possible severe respiratory side effects. The primary endpoint is incidence of serious adverse events (AEs) and respiratory AEs of special interest related to use of inhaled loxapine outside the hospital setting. Secondary endpoints include incidence of other AEs, Clinical Global Impression-Improvement scores up to 2 hours after self-administration of inhaled loxapine, time to improvement of agitation, patient satisfaction with treatment, treatment outcomes according to agitation severity and concordance between the patient (or a family member/caregiver) and the physician in scoring of agitation severity and the decision to self-administer inhaled loxapine.Ethics and disseminationThe protocol received ethics committee approval in the participating countries between January and August 2016. The results of this study will be disseminated through one or more scientific papers.Trial registration numberEudraCT2015-003331-36;NCT02525991; Pre-results.

scholarly journals Afatinib in locally advanced/metastatic NSCLC harboring common EGFR mutations, after chemotherapy: a Phase IV study

2019 ◽  
Vol 8 (3) ◽  
pp. LMT15 ◽  
Author(s):  
Sumitra Thongprasert ◽  
Sarayut L Geater ◽  
Dana Clement ◽  
Amr Abdelaziz ◽  
Jasmin Reyes-Igama ◽  
...  
Keyword(s):  
Median Duration ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Egfr Mutations ◽  
Second Line ◽  
Open Label ◽  
Platinum Based Chemotherapy ◽  
Chemotherapy Patients ◽  
Phase Iv

Aim: The current study evaluated the efficacy and tolerability of second-line afatinib in patients with EGFR mutation-positive ( EGFRm+) non-small-cell lung cancer (NSCLC) following chemotherapy. Patients & methods: In this open-label, single-arm Phase IV study, patients with EGFRm+ (Del19/L858R) NSCLC who had progressed following platinum-based chemotherapy received afatinib (starting dose 40 mg/day). The primary end point was confirmed objective response. Results: 60 patients received afatinib for a median duration of 11.5 months. 50% of patients had a confirmed objective response, of median duration 13.8 months. Median progression-free survival was 10.9 months. The most common treatment-related adverse events were diarrhea (72%), rash (28%) and paronychia (23%). Conclusion: Our data support the use of afatinib (40 mg/day) as an effective and well-tolerated second-line treatment in EGFRm+ NSCLC.

A study protocol: co-designing a mobile application to enhance communication, safety and wellbeing for people living at home with early stage dementia (Preprint)

2020 ◽  
Author(s):  
Karen Davies ◽  
Bie Nio Ong ◽  
Sudeh Cheraghi-Sohi ◽  
Katherine Perryman ◽  
Caroline Sanders
Keyword(s):  
Mobile Application ◽  
Design Research ◽  
Early Stage ◽  
Design Method ◽  
Mobile Apps ◽  
Care Service ◽  
Normalisation Process Theory ◽  
Policy And Practice ◽  
People With Dementia ◽  
At Home

BACKGROUND Background: There is a growing interest in using mobile applications in supporting health and wellbeing. Evidence directly from people with dementia regarding the acceptability, usability and usefulness of mobile apps is limited. It builds on ‘My Health Guide’ which was co-designed with people with cognitive disabilities. . OBJECTIVE Objective This paper describes the protocol of a study evaluating an app designed for supporting wellbeing with people living with dementia, specifically focusing on enhanced safety through improved communication METHODS Method: The study will employ design research, using participatory qualitative research methods over three cycles of evaluation with service users, their families and practitioners. The study will be developed in partnership with a specialist home care service in England. A purposive case selection will be used to ensure that the cases exemplify differences in experiences. The app will be evaluated in a ‘walkthrough’ workshop by people living with early stage dementia and then trialled at home by up to 12 families in a ‘try-out’ cycle. An amended version will be evaluated in a final ‘walkthrough’ workshop in cycle 3. Data will be collected from at least four data sources during the try-out phase and analysed thematically (people with dementia, carers, practitioners and app usage). An explanatory, multiple-case study design will be used to synthesise and present the evidence from the three cycles drawing on Normalisation Process Theory to support interpretation of the findings. RESULTS Results: The study is ready to be implemented but has been paused to protect vulnerable individuals during the Coronavirus in 2020. The findings will be particularly relevant for understanding how to support vulnerable people living in the community during social distancing and the period following the pandemic, as well as providing insight into the challenges of social isolation arising from living with dementia CONCLUSIONS Discussion: Evaluating a mobile application for enhancing communication, safety and wellbeing for people living with dementia contributes to key ambitions enshrined in policy and practice, championing the use of digital technology and supporting people with dementia to live safely in their own homes. The study uses a co-design method to enable the voice of users with dementia to highlight the benefits and challenges of technology and shape future development of apps that potentially enhances safety through improved communication.

Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial

2020 ◽  
Vol 16 (27) ◽  
pp. 2035-2044
Author(s):  
Charlien Berghen ◽  
Steven Joniau ◽  
Annouschka Laenen ◽  
Gaetan Devos ◽  
Kato Rans ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Lymph Node Involvement ◽  
Androgen Deprivation ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Substantial Risk

Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 ( ClinicalTrials.gov )

scholarly journals Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study

Pituitary ◽  
2021 ◽  
Author(s):  
Susan L. Samson ◽  
Feng Gu ◽  
Ulla Feldt-Rasmussen ◽  
Shaoling Zhang ◽  
Yerong Yu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Rescue Therapy ◽  
Antidiabetic Drugs ◽  
Cushing's Disease ◽  
Oral Antidiabetic Drugs ◽  
Open Label ◽  
Oral Antidiabetic ◽  
Open Label Phase ◽  
Core Phase ◽  
Phase Iv

Abstract Purpose Pasireotide is an effective treatment for acromegaly and Cushing’s disease, although treatment-emergent hyperglycemia can occur. The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs. Methods Multicenter, randomized, open-label, Phase IV study comprising a core phase (≤ 16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383). Adults with acromegaly (n = 190) or Cushing’s disease (n = 59) received long-acting (starting 40 mg IM/28 days) or subcutaneous pasireotide (starting 600 µg bid), respectively. Patients with increased fasting plasma glucose (≥ 126 mg/dL on three consecutive days) during the 16-week pre-randomization period despite metformin/other oral antidiabetic drugs were randomized 1:1 to open-label incretin-based therapy (sitagliptin followed by liraglutide) or insulin for another 16 weeks. The primary objective was to evaluate the difference in mean change in HbA1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms. Results Eighty-one (32.5%) patients were randomized to incretin-based therapy (n = 38 received sitagliptin, n = 28 subsequently switched to liraglutide; n = 12 received insulin as rescue therapy) or insulin (n = 43). Adjusted mean change in HbA1c between treatment arms was – 0.28% (95% CI – 0.63, 0.08) in favor of incretin-based therapy. The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%). Forty-six (18.5%) patients were managed on metformin (n = 43)/other OAD (n = 3), 103 (41.4%) patients did not require any oral antidiabetic drugs and 19 patients (7.6%) were receiving insulin at baseline and were not randomized. Conclusion Many patients receiving pasireotide do not develop hyperglycemia requiring oral antidiabetic drugs. Metformin is an effective initial treatment, followed by incretin-based therapy if needed. ClinicalTrials.gov ID: NCT02060383.

281 JAVELIN Medley VEGF: phase 2 study of avelumab + axitinib in patients with previously treated non-small cell lung cancer (NSCLC) or treatment naive, cisplatin-ineligible urothelial cancer (UC)

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A307-A307
Author(s):  
Gabriella Galffy ◽  
Iwona Lugowska ◽  
Elena Poddubskaya ◽  
Byoung Chul Cho ◽  
Myung-Ju Ahn ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Maintenance Treatment ◽  
Locally Advanced ◽  
Small Cell Lung ◽  
Open Label ◽  
Platinum Based Chemotherapy ◽  
Open Label Phase ◽  
Treatment Naïve ◽  
Previously Treated ◽  
Grade 3

BackgroundAvelumab, a human anti–PD-L1 monoclonal antibody, has shown a manageable safety profile and antitumor activity in multiple tumor types, including platinum-resistant metastatic or recurrent NSCLC,1 and is approved for patients with locally advanced or metastatic UC who have progressed after ≥1 previous line of platinum-based chemotherapy2 3 and as maintenance treatment for those who have not progressed with platinum-based chemotherapy.4 JAVELIN Medley VEGF (NCT03472560) evaluated the efficacy and safety of avelumab + axitinib, a potent inhibitor of VEGFR 1, 2, and 3, in patients with advanced or metastatic NSCLC or UC.MethodsEligible patients with NSCLC had received ≥1 prior platinum-containing therapy and ≤2 prior lines of systemic therapy for locally advanced or metastatic disease; patients with UC were treatment naive in the locally advanced or metastatic setting and ineligible for cisplatin-containing chemotherapy. Patients were immune checkpoint inhibitor naïve and received avelumab 800 mg intravenously every 2 weeks + axitinib 5 mg orally twice daily. The primary endpoint was confirmed objective response (OR) per investigator assessment (RECIST 1.1). Secondary endpoints included progression-free survival (PFS) and safety. PD-L1 expression was assessed in baseline tumor samples (Ventana SP263 assay). Data have not undergone standard quality checks and are subject to change due to COVID-19–related healthcare burden.ResultsA total of 41 patients with NSCLC and 20 with UC received avelumab + axitinib. The confirmed OR rate was 31.7% (95% CI, 18.1–48.1) in the NSCLC cohort and 10% (95% CI, 1.2–31.7) in the UC cohort (all partial responses); 16 patients (39.0%) and 5 (25.0%) had stable disease, respectively. Responses were observed regardless of PD-L1 expression status. Median PFS was 5.5 months (95% CI, 2.5–7.0) in the NSCLC cohort and 2.3 months (95% CI, 1.8–5.6) in the UC cohort. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 24 patients (58.5%) in the NSCLC cohort; the most common was hypertension (n=7 [17.1%]). Grade ≥3 TRAEs occurred in 9 patients (45.0%) in the UC cohort; the most common were amylase increased, asthenia, decreased appetite, and palmar-plantar erythrodysesthesia syndrome (n=2 [10%] each). One patient in each cohort experienced a TRAE that led to death (gastric perforation and urinary bladder hemorrhage).ConclusionsAvelumab + axitinib showed antitumor activity and a manageable safety profile in patients with advanced or metastatic NSCLC or UC consistent with findings from studies of each drug alone and in combination.Trial RegistrationNCT03472560Ethics ApprovalThe study was approved by each site’s independent ethics committee.ConsentN/AReferencesGulley JL, Rajan A, Spigel DR, et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol 2017;18:599–610.Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018;19:51–64.Bavencio(avelumab) injection. [package insert] Darmstadt, Germany: Merck KGaA; 2019.US Food and Drug Administration. FDA approves avelumab for urothelial carcinoma maintenance treatment. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment. Accessed August 19, 2020.

scholarly journals Quit Experiences among Primary Care Patients Enrolled in a Smoking Cessation Pilot RCT Early in the COVID-19 Pandemic

2021 ◽  
Vol 18 (3) ◽  
pp. 1011
Author(s):  
Andrea A. Joyce ◽  
Grace M. Styklunas ◽  
Nancy A. Rigotti ◽  
Jordan M. Neil ◽  
Elyse R. Park ◽  
...  
Keyword(s):  
Primary Care ◽  
Text Messaging ◽  
Risk Perceptions ◽  
Environmental Changes ◽  
Age Groups ◽  
Text Messages ◽  
Increased Risk ◽  
Primary Care Patients ◽  
The Impact ◽  
At Home

The impact of the COVID-19 pandemic on US adults’ smoking and quitting behaviors is unclear. We explored the impact of COVID-19 on smoking behaviors, risk perceptions, and reactions to text messages during a statewide stay-at-home advisory among primary care patients who were trying to quit. From May–June 2020, we interviewed smokers enrolled in a 12-week, pilot cessation trial providing text messaging and mailed nicotine replacement medication (NCT04020718). Twenty-two individuals (82% white, mean age 55 years), representing 88% of trial participants during the stay-at-home advisory, completed exit interviews; four (18%) of them reported abstinence. Interviews were thematically analyzed by two coders. COVID-19-induced environmental changes had mixed effects, facilitating quitting for some and impeding quitting for others. While stress increased for many, those who quit found ways to cope with stress. Generally, participants felt at risk for COVID-19 complications but not at increased risk of becoming infected. Reactions to COVID-19 and quitting behaviors differed across age groups, older participants reported difficulties coping with isolation (e.g., feeling disappointed when a text message came from the study and not a live person). Findings suggest that cessation interventions addressing stress and boredom are needed during COVID-19, while smokers experiencing isolation may benefit from live-person supports.

scholarly journals What does effective end-of-life care at home for children look like? A qualitative interview study exploring the perspectives of bereaved parents

2021 ◽  
pp. 026921632110233
Author(s):  
Cari Malcolm ◽  
Katherine Knighting
Keyword(s):  
End Of Life ◽  
End Of Life Care ◽  
Care Service ◽  
Life Care ◽  
Care Providers ◽  
Specialist Care ◽  
Bereaved Parents ◽  
Home Based ◽  
Qualitative Interview Study ◽  
At Home

Background: End-of-life care for children with life-shortening conditions is provided in a range of settings including hospital, hospice and home. What home-based, end-of-life care should entail or what best practice might look like is not widely reported, particularly from the perspective of parents who experienced the death of a child at home. Aim: To explore the value and assess the effectiveness of an innovative model of care providing home-based, end-of-life care as perceived by families who accessed the service. Design: A qualitative descriptive study design was employed with in-depth semi-structured interviews conducted with bereaved parents. Setting/participants: Thirteen bereaved parents of 10 children supported by the home-based end-of-life care service. Results: Parents reported effective aspects of end-of-life care provided at home to include: (1) ability to facilitate changes in preferred place of death; (2) trusted relationships with care providers who really know the child and family; (3) provision of child and family-centred care; (4) specialist care and support provided by the service as and when needed; and (5) quality and compassionate death and bereavement care. Parents proposed recommendations for future home-based end-of-life care including shared learning, improving access to home-based care for other families and dispelling hospice myths. Conclusion: Parents with experience of caring for a dying child at home offer valuable input to future the policy and practice surrounding effective home-based, end-of-life care for children. New models of care or service developments should consider the key components and attributes for effective home-based end-of-life identified by bereaved parents in this study.

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