Dataset Information

A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)

ABSTRACT: Interventions: Crushed Famotidine tablet for oral consumption, 40 mg every 24 hours for 5 days, within 24 hours of baseline assessments, administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. Crushed Dexamethasone for oral consumption, 8mg once per day in the morning for 5 days and to be commenced before midday on the first day or the next morning (if baseline assessments are completed in the afternoon), administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. Isotonic fluid administered as a parenteral infusion, at 10 – 20 mL / kg / 24-hours, commenced on on completion of the baseline assessments (unless dehydrated at the time the study is commenced where the treating clinician’s discretion may be used in the first 24 hours). Primary outcome(s): The primary outcome is whether this study is feasible to extend to a fully powered phase III clinical trial. Feasibility is defined as: 1.An average of one participant identified per site every eight weeks using recruitment tracking data bases; 2.One participant recruited per site every 12 weeks using recruitment racking databases; and 3.Collect data for >80% of people randomised, to the primary endpoint of 120 hours or study exit assessed by reviewing the data entry into the study data base.. [On completion of the study ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Bowel Cancer,Bowel Obstruction,Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Malignant Bowel Obstruction

PROVIDER: 2472996 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:This project aimed to characterize the impact of high-intensity interval exercise (HIIE) vs. moderate-intensity continuous exercise (MICE) on immune cell proteomics. In a randomized crossover study with 23 young, recreationally active runners, we isolated peripheral blood mononuclear cells (PBMCs) before, immediately after, and 1h after HIIE and MICE, respectively. After completion of the study, PBMCs were used to (i) quantify exercise-induced immune cell shifts within the PBMC compartment via flow cytometry and to (ii) perform untargeted proteomics via LC-MS/MS. The study was prospectively registered in the German Clinical Trials Register (DRKS00017686) and was approved by the local ethics committee of the German Sport University Cologne. Recreationally active runners between 18 and 35 years were considered eligible, given they did not demonstrate any previous medical record of muscle disorders, cardiac or renal diseases, or regular intake of medication or nutritional supplements. Participants were scheduled for a total of three visits to an exercise physiology laboratory of the German Sport University Cologne: baseline testing, a HIIE session, and a MICE session. All participants were asked to arrive overnight-fasted and to refrain from alcohol and caffeine intake in the 24 hours prior to each visit. All assessments were carried out between 07:00 and 10:00 am, to account for a potential circadian impact on performance and biological outcomes. The minimum timeframe between each of the three visits was 72 hours, to prevent potential carryover effects. During baseline testing, anthropometric and demographic characteristics of the participants were assessed, and a cardiopulmonary exercise test (CPET) was performed on a treadmill. Peak oxygen uptake (V̇O2peak) was calculated as the highest 15-second interval during the CPET. To prevent sequence effects participants were then randomized into one of two exercise intervention sequences: HIIE-MICE or MICE-HIIE. The randomization was carried out as concealed allocation (1:1) following the minimization procedure by Pock and Simon (REF) with age, BMI, and V̇O2peak as stratification factors. Exercise intensities for the HIIE and MICE session were calculated as percent of V̇O2peak for each participant to ensure that all participants exercised at the same intensity. The exercise conditions were matched for duration and energy expenditure as described previously (REF) to isolate exercise intensity as the only differing variable. During MICE participants performed a warm-up for 10 min at a self-selected intensity, followed by a 5 min break. Participants then ran for 50 min at 70 % of their V̇O2peak. During HIIE, participants performed 7 min of warm-up and cool-down at 70% V̇O2peak with six bouts of high-intensity running at 90 % V̇O2peak in between. Each high-intensity bout lasted 3 min, followed by 3 min of active recovery at 50 % V̇O2peak. For each measurement timepoint 24 mL of whole blood were drawn from a median antecubital vein into EDTA tubes.

Dataset Information

A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)

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