Laxative management in ambulatory cancer patients on opioid therapy: a prospective, open-label investigation of polyethylene glycol, sodium picosulphate and lactulose

2011 ◽  
Vol 21 (1) ◽  
pp. 131-140 ◽  
Author(s):  
S. WIRZ ◽  
J. NADSTAWEK ◽  
C. ELSEN ◽  
U. JUNKER ◽  
H.C. WARTENBERG
Keyword(s):  
Polyethylene Glycol ◽  
Cancer Patients ◽  
Opioid Therapy ◽  
Open Label ◽  
Sodium Picosulphate

scholarly journals Effectiveness in Bowel Cleansing and Patient Tolerability of Polyethylene Glycol versus Sodium Picosulphate in Patients Undergoing Colonoscopy

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Amit Kumar Jaiswal ◽  
Shatdal Chaudhary
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Lesion Detection ◽  
Open Label ◽  
Split Dose ◽  
Sodium Picosulphate ◽  
Bowel Cleansing ◽  
Colonic Preparation ◽  
Sodium Picosulfate ◽  
Structured Questionnaire

Introduction. Colonoscopy is considered as a gold standard investigation for screening of colorectal cancer and other lower gastrointestinal pathologies. Adequate bowel preparation is absolutely necessary for a fruitful colonoscopy. Various bowel cleansing agents are being used for his purpose. The aim of the present study was to compare the two bowel cleansing agents: a single dose of Polyethylene Glycol (PEG) solution and a split dose of Sodium Picosulfate (Na PICOSUL) tablet with regards to cleansing efficacy and tolerability among the patients scheduled for colonoscopy. Methods. It is an open-label hospital-based observational study. A total of sixty-four patients were grouped randomly into two groups of bowel cleansing agents that are PEG and Na PICOSUL during the study period between 1st December 2015 and 30th November 2016. Patients’ tolerability was evaluated using a structured questionnaire, and the bowel cleansing efficacy was evaluated using the Aronchick Bowel Preparation Scale (ABPS). Results. The group that received PEG solution was found to have better efficacy than that which received Na PICOSUL tablet (63.3% versus 29.4%, respectively, with a P value < 0.028) with excellent grade as per ABPS. The Na PICOSUL group was found better in terms of tolerability than the PEG group as nausea/vomiting was encountered significantly higher in the PEG group than in the Na PICOSUL group (43.3% versus 11.8%, respectively, with a P value < 0.01). Conclusions. Colonic preparation with a split dose of Na PICOSUL tablet was better tolerated than the evening before regimen of PEG solution. However, PEG solution was found to be more efficacious in bowel cleansing, but procedural performance and lesion detection were similar for both agents.

Su2051 Combined Polyethylene Glycol and Sodium Picosulphate for Disimpaction in Children With Chronic Constipation and Palpable Faecaloma

2015 ◽  
Vol 148 (4) ◽  
pp. S-585 ◽  
Author(s):  
Bridget R. Southwell ◽  
Lauren D. Dughetti ◽  
Julie A. Jordan-Ely ◽  
Kyla M. Dobson ◽  
Lefteris Stathopolous ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Chronic Constipation ◽  
Sodium Picosulphate

Efficacy and safety evaluation of HLX10 (a recombinant humanized anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: A single-arm, open-label, phase 2 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17510-e17510
Author(s):  
Lingying Wu ◽  
Xiumin Li ◽  
Jing Wang ◽  
Lijing Zhu ◽  
Ruifang An ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Advanced Cervical Cancer ◽  
Phase 2 ◽  
First Line ◽  
Standard Chemotherapy ◽  
Open Label ◽  
Phase 2 Study ◽  
Line Standard

e17510 Background: Limited effective treatments are available for advanced cervical cancer patients who progress after first-line chemotherapy. Historic data indicate PD-1 antibodies have significant activity in advanced cervical cancer patients. This study was designed to determine the efficacy and safety of HLX10 (a recombinant humanized anti-PD-1 monoclonal antibody) plus albumin-bound paclitaxel in patients with advanced cervical cancer who have progressed on or are intolerant to first-line standard chemotherapy. Methods: This is an ongoing single-arm, open-label, multicenter, two-stage phase 2 study (NCT04150575). 143 eligible patients aged between 18 and 75, with histologically or cytologically diagnosed cervical cancer and positive PD-L1 expression (combined positive score [CPS] ≥1) were planned to be enrolled and given intravenous infusion of HLX10 (4.5 mg/kg) plus albumin-bound paclitaxel (260 mg/m2) every 3 weeks. Stage one (N = 20) was a safety run-in and preliminary efficacy exploration study with primary endpoints of adverse events, serious adverse events and objective response rate (ORR, assessed by IRRC per RECIST v1.1). In this stage, after all patients completed two tumor evaluations (every 6 weeks), a safety evaluation and a preliminary evaluation of anti-tumor efficacy were conducted to determine whether to proceed to the second stage (N = 123). Stage two is a single-arm, open-label, multicenter, phase 2 study with primary endpoint of ORR assessed by IRRC per RECIST v1.1. Results: Here we report the stage one results (safety and preliminary efficacy) of HLX10 in advanced cervical cancer patients. By cut-off date Oct 14, 2020, 21 eligible patients with median age of 50 (range: 31–65) and average CPS of 39.33 were enrolled; the median follow-up duration was 4.34 months. 71.4% patients had ECOG PS 1. The ORR assessed by IRRC and investigators were 52.4% (95% CI: 29.8%, 74.3%) and 42.9% (95% CI: 21.8%, 66.0%), respectively. The most common grade 3 or worse treatment-emergent adverse events (TEAEs) were decreased neutrophil counts (n = 7, 33.3%), decreased white blood cell count (n = 6, 28.6%) and anemia (n = 4, 19.0%). No TEAEs leading to drug discontinuation were observed. One death (multiple organ dysfunction syndrome) possibly related to treatment was reported. Conclusions: Stage one results demonstrated a manageable safety profile and encouraging efficacy (ORR 52.4%) of HLX10 plus albumin-bound paclitaxel in advanced cervical cancer patients who have progressive disease or intolerable toxicity to first-line standard chemotherapy, representing a novel potential treatment option that warranted further investigation. Clinical trial information: NCT04150575.

scholarly journals 355 Pembrolizumab and bevacizumab in platinum resistant epithelial ovarian cancer patients

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A382-A382
Author(s):  
Judith Michels ◽  
Jean-Sebastien Frenel ◽  
Catherine Genestie ◽  
François Ghiringhelli ◽  
Caroline Brard ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clin Oncol ◽  
Cancer Patients ◽  
Bowel Perforation ◽  
Phase Iii ◽  
Antiangiogenic Agents ◽  
List Type ◽  
Open Label ◽  
Platinum Resistant ◽  
Flat Dose

BackgroundThere is a medical need in platinum resistant ovarian cancer patients. Median progression-free survival (PFS) is 3.4 months with chemotherapy and 6.7 months with chemotherapy-bevacizumab combination regimens.1 RECIST overall response rate (ORR) is 11.8% and 27.3%, respectively. The ORR is 15.9% for bevacizumab as a monotherapy with a median PFS of 4.4 months.2MethodsNCT03596281 An open-label phase 1b trial with a modified toxicity probability interval design to evaluate the combination of a flat dose of 400mg bevacizumab for 6 cycles and 200mg pembrolizumab until disease progression, unacceptable toxicity or completed 24 months of treatment in patients with platinum resistant ovarian cancer. The primary evaluation criteria is safety, the secondary endpoint is the efficacy.Results19 patients have been enrolled between January 2019 and February 2021 in 6 French centers. Patients‘ characteristics are reported (table 1). No dose limiting toxicities were observed. Grade 3 treatment related adverse events occurred in 3 patients (i.e. arterial thromboembolism, bowel perforation, proteinuria and sepsis). No grade 4/5 toxicities were induced. A median of 7 cycles (range 3–14) were administered. Median follow-up of patients was 4.1 months (1.8–23). The RECIST ORR was 26.3% (1 complete response and 4 partial responses) (table 2). The disease control rate was 78.9%. The time to progression was not yet reached in 6 patients. The ORR was equivalent whether patients have been pretreated or not with bevacizumab (27.3 and 25% respectively) (table 3). The ORR according to the combined positive score (CPS) for the evaluation of PD-L1 was 50.0% for CPS≥10% (n=4), 30.0% for a CPS≥1% (n=10) and 25.0% for CPS<1 (n=8) (table 4).ConclusionsA chemotherapy-free regimen combining pembrolizumab and bevacizumab was well tolerated and showed encouraging results in heavily pretreated platinum resistant ovarian cancer patients independent of their previous challenge with antiangiogenic agents.AcknowledgementsFunding for this research was provided by Fondation Cancer du Luxembourg and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationNCT03596281ReferencesPujade-Lauraine E, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Onco Off J Am Soc Clin Oncol 32,1302–1308 (2014).Cannistra SA, et al. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol Off J Am Soc Clin Oncol 33,5180–5186 (2007).Ethics ApprovalThis study was approved by CPP Sud Méditerranée V institution’s Ethics Board; approval number 18.020 (EudraCT number 2017-004197-34).ConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.

scholarly journals Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

2019 ◽  
Vol 4 (07) ◽  
Author(s):  
Edit Nadasi ◽  
Gellert Cseh
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Study Protocol ◽  
Negative Energy ◽  
Malignant Diseases ◽  
Open Label ◽  
Multicentre Clinical Trial ◽  
Patients With Cancer ◽  
Extra Energy ◽  
Oral Nutritional Supplements

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

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