A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2049589 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: Patients receiving abraxane chemotherapy for pancreatic cancer, breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer will be recruited into the study to document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. Examples of neurotoxicity seen with abraxane therapy include sensory dysasthesia including numbness and tingling in the hands and feet.
Patients will be assessed monthly from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment, to a maximum period of 2 years following enrolment.
Primary outcome(s): To document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment.
The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.[Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.]
Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective
| 2462598 | ecrin-mdr-crc
Project description:Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40 percent of patients undergoing chemotherapy.
American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.
PerOx Quench has unique membrane protection and anti-oxidative function as a special food, that’s why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.
| 2198947 | ecrin-mdr-crc
Project description:Charcot-Marie-Tooth 1A is a demyelinating peripheral neuropathy caused by the duplication of peripheral myelin protein 22 (PMP22), which produces muscle weakness and loss of sensation in the hands and feet. A recent case-only genome wide association study by the Inherited Neuropathy Consortium identified a strong association between variants in signal induced proliferation associated 1 like 2 (SIPA1L2) and strength of foot dorsiflexion. To validate SIPA1L2 as a candidate modifier, and to assess its potential as a therapeutic target, we engineered mice with a deletion in SIPA1L2 and crossed them to the C3-PMP22 mouse model of CMT1A. We performed neuromuscular phenotyping and identified an interaction between Sipa1l2 deletion and muscular endurance decrements assayed by wire-hang duration in C3-PMP22 mice, as well as several interactions in femoral nerve axon morphometrics such as myelin thickness. Gene expression changes suggested an involvement of Sipa1l2 in cholesterol biosynthesis, which was also implicated in C3-PMP22 mice. Though several interactions between Sipa1l2 deletion and CMT1A-associated phenotypes were identified, validating a genetic interaction, the overall effect on neuropathy was small.
2023-12-12 | GSE249764 | GEO
Project description:Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy. This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste disorders and swallowing difficulties.
The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients’ daily lives and quality of life.
| 2187607 | ecrin-mdr-crc
Project description:Background and study aims
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common reasons that colorectal cancer patients cannot maintain their routine chemotherapy schedules. CIPN involves pain, numbness, tingling and sensitivity to cold in the hands and feet and is often very painful and stressful. Some medications are used for pain relief, but they are often not effective. As a result, there has been renewed interest in alternative therapies that stimulate the hand muscles, such as exercise or massage to relieve the neuropathic symptoms.
This study aims to look at the effectiveness of a handicraft program as rehabilitation for colorectal cancer patients with CIPN, which involves basic craftwork to encourage the use of the minor muscles of the hands to make and decorate handicrafts.
Who can participate?
Adults with colorectal cancer who received chemotherapy
What does the study involve?
This rehabilitation program comes in the form of the handicraft class, which involves decorating crafts such as a hand mirror, a business card holder, a table clock, and a picture frame with lacquerware, using Korean traditional lacquerworks. This is performed once a week, for 2 hours per each session, for a total of 4 weeks. All volunteers will participate in same program. The effectiveness of this program will be evaluated by using a questionnaire.
| 2412118 | ecrin-mdr-crc
Project description:<p>Charcot Marie Tooth disease (CMT) is an umbrella term that covers any inherited peripheral neuropathy. People with CMT have a problem with the nerves that go to the feet and hands that cause muscle and sensation loss, as well as difficulty with balance. There are at least forty genes that, when mutated, cause CMT. The purpose of this study is to look at the natural history of CMT to see how it changes over time. Particular emphasis will be put on studying people with CMT1B, CMT2A, CMT4A, and CMT4C, though all people with CMT are encouraged to participate. Participants are invited back on a yearly basis to determine how the changes are occurring.</p> <p> Objectives: <ul> <li>Determine the natural history and genotype-phenotype correlations of disease-causing mutations in CMT1B, CMT2A, CMT4A and CMT4C as well as other forms of CMT</li> <li>Determine the capability of the newly developed CMTPeds score and the Minimal Dataset to measure impairment and perform longitudinal measurements in patients with multiple forms of CMT over a ten-year window</li> </ul> </p> <p>This is a longitudinal study of individuals with CMT. Study participants will be invited to be re-evaluated every year. Evaluations will consist of neurological histories and examinations, selected nerve conduction studies (NCS) as well as completion of assorted clinical outcome measures including the CMTNS, Minimal Dataset, and Peds CMT Scale. Selected CMT patients and controls will also receive glabrous skin biopsies.</p>
| phs001419 | dbGaP
Project description:This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
| 2319930 | ecrin-mdr-crc
Project description:Gene expression analysis of 2-month-old Ctrl and Tfam-SCKO mice. At this age mitochondrial function is disrupted in the Schwann cells of Tfam-SCKO mice ,but their nerves display only very limited pathology. Mitochondrial dysfunction is a common cause of peripheral neuropathy. Much effort has been devoted to examining the role played by neuronal/axonal mitochondria, but how mitochondrial deficits in peripheral nerve glia (Schwann cells, SCs) contribute to peripheral nerve diseases remains unclear. Here, we investigate a mouse model of peripheral neuropathy secondary to SC mitochondrial dysfunction (Tfam-SCKOs). We show that disruption of SC mitochondria activates a maladaptive integrated stress response through actions of heme-regulated inhibitor kinase (HRI), and causes a shift in lipid metabolism away from fatty acid synthesis toward oxidation. These alterations in SC lipid metabolism result in depletion of important myelin lipid components as well as in accumulation of acylcarnitines, an intermediate of fatty acid b-oxidation. Importantly, we show that acylcarnitines are released from SCs and induce axonal degeneration. A maladaptive integrated stress response as well as altered SC lipid metabolism are thus underlying pathological mechanisms in mitochondria-related peripheral neuropathies. Total RNA samples were prepared by isolating and pooling RNA from three different 2-month-old MPZ-Tfam KO and Ctrl mice. 2 replicates per genotype were used in this experiment and they were prepared entirely independently.
2013-03-13 | E-GEOD-44605 | biostudies-arrayexpress
Project description:The deletion of the POZ domain of the transcription factor Miz1 leads to a late onset neuropathy with subsequent spontaneous regeneration in mice. In this study, we aim to identify genes that are involved in the development of this neuropathy. We traced first gene regulatory changes in sciatic nerve tissue from Miz1∆POZ mice to 30 days after birth. At this time point, we harvested samples of sciatic nerve tissue from several mice and performed RNAseq analysis to identify differentially expressed genes between Miz1∆POZ and wild type mice.
2018-03-14 | E-MTAB-5600 | biostudies-arrayexpress
Project description:Primary objectives: ?To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer.?To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy.?To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy.?To explore the incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.?To explore the incidence of adverse events by severity, of serious adverse events, of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity.?To assess E-52862 plasma exposure associated with the treatment.
Primary endpoints: Efficacy endpoints:-Evolution of the clinical Total Neuropathy Score (cTNS).-Change from baseline of the reduced Total Neuropathy Score (rTNS).-Evolution of cold-induced pain intensity.-Change from baseline of the number and duration of signs and symptoms of OXL-induced acute neuropathy assessed with the specific OXL-induced neuropathy questionnaire.-Level of peripheral sensory neuropathy toxicity at each visit assessed with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria.-Time to the first occurrence of NCI-CTCAE grade 2, 3 or 4 symptomatic neuropathy.-Change from baseline of the amplitudes of sensory and motor nerve action potentials and of the sensitive and motor nerve conduction velocities measured in the nerve conduction tests.-Evolution of patients’s quality of life assessed with the Quality of Life Questionnaire C30 (QLQ-C30) with the module for chemotherapy-induced neuropathy (QLQ-CIPN20).-Proportion of patients who meet any of the following definitions of neuropathy at the end of the study: a) at least subclinical neuropathy: cTNS >2, b) manifest neuropathy: rTNS > or equal 5, c) symptomatic neuropathy: grade >1 NCI-CTCAE toxicity, and d) severe neuropathy: grade > or =3 NCI-CTCAE toxicity.-Incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.-Total cumulative dose of OXL administered.
Safety endpoitns:-Incidence of adverse events by severity, of serious adverse events, of adverse events leading to E-52862 discontinuation and of adverse events related to E-52862 by severity. Values for these variables will be obtained in all visits of the study, except in the screening visit.-E-52862 plasma concentration associated with the treatment.
| 2530562 | ecrin-mdr-crc