Ibudilast for the prevention of nerve symptoms caused by oxalipatin chemotherapy, in patients with metastatic gastrointestinal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Chemotherapy Induced Peripheral Neuropathy (cipn),Neurological-other Neurological Disorders,Cancer-bowel-anal,Cancer-bowel-small Bowel (duodenum And Ileum),Acute Neurotoxicity,Cancer-pancreatic,Cancer-stomach,Metastatic Gastrointestinal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-liver
PROVIDER: 2466639 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: Ibudilast 30mg oral twice a day for prevention of acute neurotoxicity for the duration of taking oxaliplatin chemotherapy commencing 2 days prior to starting oxaliplatin.
Primary outcome(s): Acute neurotoxicity assessed by the Oxaliplatin Acute Symptom Questionnaire[Day 3 of week 4 for CAPOX and day 3 of week 5 for FOLFOX.]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy
| 2469007 | ecrin-mdr-crc
Project description:<p>The Study to Assess the Cardiovascular, Cognitive, and Subjective Effects of Atomoxetine in Combination with Intravenous Methamphetamine started in 2007 and ended in 2011. It was a small pilot study that included methamphetamine abusing individuals and healthy control participants aged 18-50 years. Participants who qualified over the telephone were scheduled to visit the London Laboratory at the UCLA Semel Institute for Neuroscience and Human Behavior for the In-Person Screening Phase. The screening procedures, usually scheduled over two visits, determined if participants were eligible to complete the subsequent study visits. Both groups completed identical screening procedures, including a SCID diagnostic interview to rule out any major psychiatric disorders. Methamphetamine users also answered questionnaires specific to their drug use. Urine toxicology for marijuana, opiates, cocaine, methamphetamine, and benzodiazepines were monitored at the beginning and throughout the study. Additionally, participants had blood samples to test for Rapid Plasma Reagin (exposure to syphilis), purified protein derivative (PPD), HIV and Hepatitis-C (HCV). Positive test results were relayed by a study physician and resulted in termination from continuing in the study.</p> <p>The inpatient portion of the study lasted a total of 24 days. To confirm compliance with abstinence from illicit and prescription drug use for the duration of the study, urine and breath alcohol testing was performed for both inpatient (methamphetamine users) and outpatient (healthy control) groups. Each subject was randomized to receive either atomoxetine (80 mg daily) or placebo. During inpatient days of the study, a study physician oversaw research subjects daily and experimental procedures were conducted in the General Clinical Research Center (GCRC). During drug administration sessions, heart rate and blood pressure were assessed at frequent intervals. Experimental sessions lasted around three hours and were conducted at approximately the same time of day for a given participant. Lunch was provided to participants at 11:30am with the prohibition of caffeine on study days involving methamphetamine administration. Participants were provided with smoke breaks as needed to assure that acute nicotine withdrawal did not negatively impact performance on cognitive testing. The following outlines the day to day procedures for a methamphetamine inpatient:</p> <p><b>Phase I Inpatient Study</b> (<i>15 days total</i>)<br/> <b>Days 1-3:</b> On the day of admission, participants received blood tests and an EKG in order to determine that they had no occult medical conditions which would make their participation in the study medically contraindicated. A three day washout period was provided at the beginning of the study to establish an appropriate methamphetamine-free baseline for testing. <br/> <b>Days 4-6:</b> Participants completed cognitive test batteries to assess inhibitory control including self-report measures and cognitive testing, as well as up to three MRI scanning sessions.<br/> <b>Day 7:</b> On day 7, at 9AM and 1PM, participants received methamphetamine in a single-blinded condition. It was administered as two IV infusions of 15mg separated by a 60min break. The total dose of IV methamphetamine was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in the absence of study medication.<br/> <b>Day 8:</b> On day 8 we evaluated the safety and residual effects of the methamphetamine administered on the previous day.<br/> <b>Days 9-10:</b> After demonstrating medical and psychiatric stability of the initial methamphetamine infusion, participants were then randomized to receive placebo or atomoxetine (0 or 40mg) under double-blind conditions, which would be given at 8AM on both study days. <br/> <b>Days 11-12:</b> On days 11 and 12, participants remained in the GCRC and took two doses of test compound atomoxetine (0 or 40mg) at 8AM and 8PM. On the morning of day 12, participants completed a series of cognitive testing.<br/> <b>Day 13:</b> On day 13, participants remained in the GCRC, and took two doses of the test compound atomoxetine (0 or 40mg) at 8AM and 8PM. At 9AM and noon, they received methamphetamine under double-blind conditions administered non-contingently as two infusions of 0 or 15mg by IV (intravenously), with each infusion separated by 60min. The total dose of IV methamphetamine that each participant received was 30mg. As before, participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. <br/> <b>Day 14:</b> On day 14 at 8AM, participants received their final dosing of the first test compound (atomoxetine 0 or 40mg). At 9AM and 1PM, participants selected between methamphetamine infusion or money using double-blind conditions in a multiple-choice self-administration paradigm. Participants were able to take up to two infusions of 0 or 15mg of methamphetamine, separated by 60min. The total dose of IV methamphetamine that each participant received on day 14 was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. At 5pm on day 14 discharge laboratory studies were drawn.<br/> <b>Day 15:</b> On day 15, a final EKG was performed as well as a review of discharge laboratory studies, including review of the EKG and continued medical and psychiatric stability. Upon clearance from a physician, participants were discharged on day 15. Participants spent at least 2 weeks (14 days) out of the hospital prior to returning to the UCLA GCRC for inpatient Phase II.<br/></p> <p><b>Phase II Inpatient Study</b> <i>(9 days total)</i><br/> <b>Day 1-2:</b> On the day of re-admission, participants received blood tests and an EKG. A two day washout period was provided at the beginning of the study to establish an appropriate methamphetamine free condition for safe administration of the second test compound condition. <br/> <b>Days 3-4:</b> On days 3 and 4, given medical stability, participants were then switched to the opposite test compound (atomoxetine 0 or 40mg) under double-blind conditions, in the same manner as in Days 9-10 in Phase I. <br/> <b>Days 5-6:</b> Same procedure as in Days 11-12 in Phase I but with opposite medication condition.<br/> <b>Day 7:</b> Same procedure as in Day13 in Phase I but with opposite medication condition.<br/> <b>Day 8:</b> Same procedure as in Day14 in Phase I but with opposite medication condition.<br/> <b>Day 9:</b> Same procedure as in Day14 in Phase I but with opposite medication condition.<br/> </p> <p> For healthy control participants, the study consisted of 30 days or fewer of out-patient testing. Healthy control participants had an extensive screening, including a history and physical exam performed by a study physician, an EKG, and laboratory studies performed to assess for medical or psychiatric conditions. Control participants meeting criteria were invited back to UCLA to undergo cognitive testing, and some participants received fMRI scans. Participants were required to refrain from illicit and prescription drug use for the duration of the study, which was confirmed with urine toxicology and breath alcohol level testing on examination days. Caffeine was restricted on study days for least 2 hours prior to cognitive testing and MRI scans. Participants were permitted to drink their normal daily intake of caffeine, given the caveat above. On study days, cigarette smoking was permitted to match conditions used with methamphetamine users. The incorporation of smoke breaks during the test day assured that acute nicotine withdrawal did not negatively impact performance on cognitive tests or neuroimaging. The following outlines procedures for healthy control participants:</p> <p> For normal controls, participation involved one day of outpatient screening, and one day of baseline cognitive testing and possible MRI scans. After these procedures were completed, participants were randomized to the first test compound (atomoxetine 40mg or placebo), to be taken once daily in the morning for 2 days. It was then increased to twice daily for the next 3 days, followed by a final dose (40mg or placebo) on the sixth day of study medication. Participants were also asked to bring their pill packages to assess compliance with the study medication. Additionally, control participants completed a series of repeated-measures cognitive testing (on placebo or atomoxetine, respectively) and possibly two fMRI sessions (separated by a short break).</p> <p> After at least a four-day washout period, control participants were instructed to start the opposite test compound (atomoxetine 40mg or placebo), again to be taken once daily in the morning for two days, then twice daily for 3 days, reaching the final dose (40mg or placebo) of the second test compound in the morning. Participants were again asked to bring their pill packages to assess compliance and had blood drawn to assess atomoxetine levels. Control participants then completed another series of cognitive testing and fMRI testing sessions. They were subsequently discharged from the study. Normal control participants returned two weeks after completion of both study phases in order to complete assessments to their physical and psychological status following treatment. </p>
| phs001195 | dbGaP
Project description:Human renal proximal tubule cells (RPTEC/TERT1) were exposed to one of two nephrotoxic chemicals, ochratoxin A (OA) or potassium bromate (KB), or a vehicle control (CT). The exposure regime was a repeated dosing every 24h for 5 days followed by chemical washout and 3 days of recovery with medium renewal every 24h. Total experimental duration was 8 days. Cell lysates were prepared for microarray analysis after 1 day, 3 days and 5 days of exposure, and after 3 days of recovery (day 8).
2018-09-16 | E-MTAB-7048 | biostudies-arrayexpress
Project description:Interventions: Consented participants who are scheduled for capecitabine monotherapy for breast or gastrointestinal cancer will be randomly allocated to receive concomitant oral pantoprazole 40mg daily, 4 days prior to and on the first day (total 5 doses) of either the first (group A) or second (Group B) cycle of capecitabine. Pharmacokinetic blood and urine sampling for capecitabine will be performed over eight hours on both cycle1 day 1 and cycle 2 day 1 to determine if PK parameters are different with pantoprazole. Participants will be contacted by phone a day before their course of pantoprazole begins and will receive a daily text reminder on the subsequent 4 days. A medication diary will be kept. The washout period is 21 days (in between cycle 1 day 1 and cycle 2 day 1)
Primary outcome(s): Area Under the Curve AUC(0-8) of 5”DFUR (Blood and urine sample) [Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole];Area Under the Curve AUC(0-8) of 5-FU (blood and urine sample) [Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Bio-equivalence
| 2471532 | ecrin-mdr-crc
Project description:NSG mice were IP injected with 30mg/kg busulfan. The following day, mice received 1,000,000-3,000,000 primary blasts derived from the peripheral blood of patients with ALL. Mice were monitored for engraftment for ~10-13 weeks via tail vein bleeding for engraftment. Some mice received high dose CAR-T cell therapy and an isotype control antibody treatment. RNA was isolated using miRNeasy Micro kit (Qiagen, Gaithersburg, MD, USA) and treated with RNase-Free DNase Set (Qiagen, Gaithersburg, MD, USA). RNA-seq analyses of brain sections harvested from mice treated with CAR-T cells showed significant upregulation of genes regulating the T cell receptor, cytokine receptors, T cell immune activation, T cell trafficking, and T cell and myeloid cell differentiation. Xenografts treated with CAR-T cell therapy developed neurotoxicity.
2020-03-10 | GSE121591 | GEO
Project description:RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.
PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.
| 2071054 | ecrin-mdr-crc
Project description:RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.
| 2025107 | ecrin-mdr-crc
Project description:Fifty 8-week-old C57BL/6J mice were randomly divided into five groups of ten mice. The study duration was 28 days and involved three phases, namely an adaptation phase (days 1M-^V7), a treatment phase (days 8-21), and a washout period (days 22-28). During the 14-days treatment period each mouse in the L. gasseri group, the pre-incubation group and the co-incubation group received a daily dose of 1 x 109 viable K7 cells, determined as colony forming units (cfu) on MRS agar, re-suspended in 100 M-5L of saline solution. The suspension was applied orally by the use of plastic feeding tubes for rodent oral gavage. A single dose of E. coli O157:H7 was applied on day 8 of trial (E. coli group, co-incubation group) and day 15 of trial (pre-incubation group). Each mouse received a dose of 5 x 108 viable E. coli O157:H7 cells, determined as colony forming units (cfu) on E. coli O157:H7 agar, re-suspended in 100 M-5L of saline solution. The suspension was applied intra-gastrically by the use of plastic feeding tubes for rodent oral gavage. Throughout the three phases of the study the animals were fed ad libitum a standard mouse diet and had access to water at all times. All mice were weighted weekly on days 0, 7, 14, 21, 28. Their feed intake was assessed weekly by measuring the remaining (unconsumed) food. Mice were also monitored twice daily for the clinical status and behavioral changes. End of the study period, mice were euthanized with CO2 and blood samples were obtained from the heart by cardiac puncture. For microarray analysis 300ul of blood from 4 mice in each group were transferred immediately after the cardiac puncture to tubes containing a pre-loaded RNA-later solution.
2014-01-31 | E-MEXP-3031 | biostudies-arrayexpress
Project description:RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy.
PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.
| 2028254 | ecrin-mdr-crc
Project description:Oxaliplatin-induced neuropathic pain is a common dose-limiting side effect of cancer treatment but the underlying mechanisms are largely unknown. The neuropathic pain model was established by oxaliplatin intraperitoneal administration for five consecutive days. In the present study, we performed whole genome expression microarray analysis by using spinal dorsal horn from oxaliplatin-treated and vehicle-treated rats on day 10.
2020-03-11 | GSE146739 | GEO