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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

ABSTRACT: Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

DISEASE(S): Chemotherapy-induced Peripheral Neuropathy,Pain,Peripheral Nervous System Diseases,Chemotherapy-induced Peripheral Neuropathy Symptoms,Neuropathy Peripheral

PROVIDER: 2033030 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer is the 4th most common cancer in the world among all cancer types. Chemotherapy-induced peripheral neuropathy is a common and serious side effect caused by chemotherapeutic agents, especially platinum analogues, taxanes, vinca alkaloids and bortezomib. The most commonly used chemotherapeutic agents in the treatment of colorectal cancers are platinum analogues It is known that oxaliplatin, one of the platinum analogues, causes 85-96% of chemotherapy-induced peripheral neuropathy. The most common symptoms of chemotherapy-induced peripheral neuropathy are; numbness, paresthesia, dysesthesia, pain, hypersensitivity to cold or heat, tingling, muscle cramps, distal weakness, gait disturbances, balance disorders, and impaired movement. Oxaliplatin, which is frequently used in the treatment of colorectal cancer, causes symptoms of both acute and chronic chemotherapy-induced peripheral neuropathy. There is no proven method in the treatment of chemotherapy-induced peripheral neuropathy. However, various pharmacological and non-pharmacological approaches are applied in its preventive and symptomatic treatment. Exercise and physical therapy interventions; It is stated that it improves strength, balance and other functional disorders in patients, reduces symptoms, and reduces the risk of falling by affecting gross motor dysfunctions such as balance and gait abnormalities. However, the limitations of studies on this subject in the literature draw attention. This situation suggests that new methods that can be applied in the care of cancer patients who develop peripheral neuropathy due to chemotherapy should be developed in the field of nursing. This research is the first study to evaluate the effect of hand-foot exercises on colorectal cancer patients who developed peripheral neuropathy due to platinum-based therapy. Research results; Alleviation of KBPN-induced pain and prevention of falls are important in terms of increasing the quality of life of patients and providing evidence for nursing practices by using it as a new method that can be applied in the care of cancer patients with chemotherapy-induced peripheral neuropathy. The aim of this research was to determine the effect of hand-foot exercises on the severity of pain, falls and quality of life associated with platinum-based therapy-related peripheral neuropathy in patients with colorectal cancer.

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.

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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

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