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Study on the usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms caused by peripheral intravenous administration of oxaliplatin

ABSTRACT: Interventions: 1st time chemotherapy 1.During heating is described in the report 2.If vascular pain happened, then the warming infusion is start. 3.NRS is performed for 5min, 10min, 15min. Subsequent check is performed every 15 minutes.. 4.Patient’s report is performed from day 1 to day 8. Subsequently 1.Patients select one of the following before the start of infusion. i)Warming infusion is performed from the time of the appearance of vascular pain. ii)Performed prophylactically from the beginning. Not select all. Primary outcome(s): NRS:Numeric Rating Scale Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer Patient

PROVIDER: 2625776 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background and aims: Preclinical data suggest that the chemokine receptor 2 (CCR2) is involved in the pathophysiology of neuropathic pain through modulation of neuronal excitability, synaptic transmission and activation of spinal cord microglia. CCR2-antagonists have shown to be effective in preclinical models of neuropathic pain. The aim of this study was to evaluate the analgesic efﬁcacy, safety and tolerability of a novel CCR2-antagonist, AZD2423, in patients with painful diabetic neuropathy (PDN). Methods: This was a double-blind, randomized, parallel-group, multi-center study in patients with sym- metric distal sensory polyneuropathy due to type 1 or 2 diabetes and duration of neuropathic pain between 3 months and 5 years. Concomitant treatment with neuropathic pain medications (e.g. anticon- vulsants, tricyclic antidepressants, serotonin-noradrenaline uptake inhibitors, opioids, topical lidocaine or capsaicin) was not allowed. 134 patients with PDN were equally randomized to 28 days oral admin- istration of 20 mg AZD2423, 150 mg AZD2423, or placebo. The primary efﬁcacy variable was the change of average pain score from 5-days baseline to the last 5 days of treatment, measured with numerical rating scale (NRS, 0–10). The secondary efﬁcacy measures included NRS worst pain scores, patient global impression of change, pain interference on sleep and activity, and neuropathic pain symptom inventory (NPSI). Results: The change of NRS average pain score was not signiﬁcantly different between treatment groups (AZD2423 20 mg: −1.50; AZD2423 150 mg: −1.35; placebo: −1.61). The NPSI total score and three out of ﬁve subscores (evoked pain, pressing/deep pain and paresthesia/dysesthesia) tended to be reduced more by AZD2423 150 mg than by placebo. No other secondary efﬁcacy variables differed between treatment groups. The frequency and type of adverse events for AZD2423 were similar to placebo. The achieved plasma levels of AZD2423 in the two dose groups were in line with predictions from pharmacokinetic data previously obtained in healthy volunteers. Dose-dependent increase of plasma levels of the ligand of CCR2 (CCL2; chemokine ligand 2) and decrease of the mean levels of monocytes (−27% by AZD2423 150 mg) suggested that the administrated doses of AZD2423 interacted with the CCR2 target. Conclusion: The CCR2-antagonist AZD2423 showed no analgesic efﬁcacy in PDN based on NRS average pain scores and global and functional pain outcome measures. The NPSI data suggested possible effects on certain sensory components of pain. There were no major safety or tolerability concerns.

Dataset Information

Study on the usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms caused by peripheral intravenous administration of oxaliplatin

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