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Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

ABSTRACT: Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Secondary objective: * To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale). * To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months * To assess the effects of xaliproden on the time to complete recovery from PSN * To evaluate the safety profile of xaliproden

DISEASE(S): Patient With Oxaliplatin-induced Peripheral Sensory Neuropathy After Having Completed An Oxaliplatin-containing Chemotherapy Regimen Post Complete Surgical Removal Of Primary Colorectal Tumor,Colorectal Neoplasms,Sensory Peripheral Neuropathy

PROVIDER: 2049763 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity

Project description:Primary Objective: To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred. Secondary Objective: To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN. To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4. To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale. To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.

| 2086375 | ecrin-mdr-crc

DNA methylation profiling upon treatment with NTX-301 or decitabine in AML cells

Project description:A novel hypomethylating agent NTX-301 is a promising therapeutic agent for AML patients. To examine its mechanisms of action, we produced methylome data upon treatment with NTX-301 or decitabine (DAC) in MV4-11 cell line.

2022-11-30 | GSE187291 | GEO

Gene expression profiling upon treatment with NTX-301

Project description:A novel hypomethylating agent NTX-301 is a promising therapeutic agent for AML patients. To examine its mechanisms of action, we produced gene expression data upon treatment with NTX-301 or decitabine (DAC) in AML cell lines.

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Metabolomic Profiles of Recovery from Traumatic Brain Injury

Project description:We hypothesize that differences between the metabolome of TBI patients achieving full recovery at 3 months post-injury and those with protracted recovery will provide insights into the biology of recovery and yield novel biomarkers for predicting protracted recovery. To test our hypothesis, we will perform a case-control study examining the metabolomic profile of 128 TBI patients, 18 years and older, who either have complete functional recovery at 3 months post-injury or have functional decline at 3 months post-injury. Subjects were selected from an ongoing prospective cohort of traumatic brain injury (Head Injury Serum Markers for Assessing Response to Trauma, HeadSMART. Funding for HeadSMART was provided by ImmunArray.

2017-06-19 | ST000721 | MetabolomicsWorkbench

A clinical trial to study the effects of foot bathing in patients receiving oxaliplatin containing chemotherapy in patients with colorectal cancer at Tata Memorial Hospital.

Project description:Intervention1: Warm foot bath therapy: In experimental arm, Warm foot bath therapy Each session-15min. Participants will receive warm foot bath therapy prior oxaliplatin for 15min.and post oxaliplatin for 15min.on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and in home at night once for 15min.till completion of 6cycles. In control arm, Participants will not receive the above intervention; but only receive routine treatment. Control Intervention1: standard routine treatment No interventions: In experimental arm, Warm foot bath therapy Each session-15min. Participants will receive warm foot bath therapy prior oxaliplatin for 15min.and post oxaliplatin for 15min.on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and in home at night once for 15min.till completion of 6cycles. In control arm, Participants will not receive the above intervention; but only receive standard routine treatment. Primary outcome(s): To evaluate the effects of foot bathing on peripheral neuropathy in patients receiving oxaliplatin containing chemotherapy for colorectal cancer.Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool -Assessment of CIPN on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and assessment of CIPN and associated QOL using FACT-GOG NTX tool on 1st day of 2nd and 6th chemotherapy cycle and three months after completion of 6th cycle and six months after completion of 6th cycle.

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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Project description:The aim of current study is to evaluate the possible protective role of Ketotifen against oxaliplatin-induced peripheral sensory neuropathy in patient with stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.64 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=32) which will receive 12 cycles of modified FOLFOX-6 regimen plus placebo tablets twice daily. Group II (ketotifen group; n=32) which will receive modified FOLFOX-6 regimen in addition to ketotifen 2 mg daily Blood sample collection and biochemical assessment: * Serum IL-6 as a marker of inflammation. * Serum superoxide dismutase (SOD) as a biomarker of oxidative stress. * Serum neurotensin as a biomarker for neuropathy. Assessment of oxaliplatin induced peripheral sensory neuropathy will be done through: * The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy at baseline and by the end of every two oxaliplatin cycles. * The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12" at baseline and by the end of every two oxaliplatin cycles. * The assessment of the severity of neuropathic pain through brief pain inventory short form "BPI-SF" worst item. Severity of neuropathic pain will be assessed at baseline and by the end of every two oxaliplatin cycles.

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Transcription profiling of human cells stored at ambient temperature in different storage media

Project description:This series represents the complete series of the human 293h media depleted storage on agarose / rehydration condition course analysis. Samples include Control, monolayer; Control, monolayer/full recovery, antibiotics; Spheroid, no storage; two week storage/0hr recovery; two week storage/full recovery; four week storage/0hr recovery; six week storage/0hr recovery.

2008-06-11 | E-GEOD-1364 | biostudies-arrayexpress

Expression data from Col-0 and sp1,spx2 under phosphate starvation stress and recovery after resupplying phosphate

Project description:We performed a transcriptomic analysis of Pi-starvation and recovery after resupplying Pi in Arabidopsis thaliana (Columbia-0) wild type plants and double mutant spx1,spx2. Results show that SPX1 is a Pi-dependent inhibitor of the transcription factor PHR1, a central regulatory protein in the control of transcriptional responses to Pi starvation. The analysis was performed in wild-type and double spx1,spx2 double mutant plants grown for seven days in complete (+Pi) and Pi-lacking (-Pi) Johnson solid media. Then, plants were transferred to complete medium for 4 hours to analyze the effect of resupplying plants with Pi.

2014-09-30 | E-GEOD-52046 | biostudies-arrayexpress

Long-Term Storage of Human Cells at Ambient Temperature

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