Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488963
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
The Effect of Cold Therapy on Peripheral Neuropathy
Sponsor:
Koç University
Organization:
Koç University
Study Overview
Official Title:
The Effect of Cold Therapy on Peripheral Neuropathy A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines the feasibility acceptability and efficacy of cold therapy on vincristine-induced peripheral neuropathy VIPN in pediatric patients with cancer
Vincristine VCR is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients It leads to symptoms of peripheral neuropathy numbness in the hands and feet tingling musclejoint pain burning sensation decreased peripheral reflexes and constipation These symptoms negatively affect the daily life and quality of life of children Therefore it is essential to managing peripheral neuropathy We aim to decrease the level of VIPN and pain and improve patients quality of life
Unfortunately the neurotoxicity mechanisms of vinca alkaloids are not well known which is one of the significant limitations in developing effective treatments to prevent VIPN among pediatric oncology patients We were unable to locate a randomized controlled trial that has evaluated the effectiveness tolerability and acceptability of cold therapy on VIPN for pediatric oncology patients Our study findings will be the first in Turkish national and international literature and we believe that our results will provide evidence for clinical nursing practice
Vincristine VCR is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients It leads to symptoms of peripheral neuropathy numbness in the hands and feet tingling musclejoint pain burning sensation decreased peripheral reflexes and constipation These symptoms negatively affect the daily life and quality of life of children Therefore it is essential to managing peripheral neuropathy We aim to decrease the level of VIPN and pain and improve patients quality of life
Unfortunately the neurotoxicity mechanisms of vinca alkaloids are not well known which is one of the significant limitations in developing effective treatments to prevent VIPN among pediatric oncology patients We were unable to locate a randomized controlled trial that has evaluated the effectiveness tolerability and acceptability of cold therapy on VIPN for pediatric oncology patients Our study findings will be the first in Turkish national and international literature and we believe that our results will provide evidence for clinical nursing practice
Detailed Description:
An estimated 400 000 children and adolescents ages 0-19 years old are diagnosed with cancer each year WHO 2021a More than 80 of children with cancer are cured in high-income countries where comprehensive care is generally available whereas in some low- and middle-income countries less than 30 of patients survive WHO 2021b Lam et al 2019 Considering the global increase in childhood cancer incidence Bhakta et al 2019 Ward et al 2019 it is critical to characterize the long-lasting side effects of treatment for childhood cancer and accurately assess monitor and ultimately develop management strategies to prevent treatment-related side effects Kandula et al 2016 Many chemotherapy agents used in cancer treatment can cause acute and chronic peripheral nervous system injury and dysfunction termed chemotherapy-induced peripheral neuropathy CIPN Rodwin et al 2021 Kandula et al 2016 CIPN is a significant problem becoming more prevalent as oncological therapies that use potentially neurotoxic chemotherapy enhance cancer cure and survival Cavaletti et al 2019 Peripheral neuropathy is a severe side effect of chemotherapeutic agents and it can damage the sensory-motor-autonomic regions of the peripheral nervous system Park et al 2013 Kandula et al 2016 Peripheral nerve toxicity has been described with vinca alkaloids platinum compounds taxanes epothilones bortezomib and thalidomide Kandula et al 2016 Kandula et al 2018 Cavaletti et al 2019 Acute CIPN can develop during chemotherapy necessitating dosage reduction or discontinuation and reducing survival Colvin 2019 In a recent systematic review of 42 publications 2009-2020 the reported CIPN incidence ranges from 28 to 100 depending on risk variables Sensory motor autonomic CIPN and pain had incidence rates of 2-28 50-72 08-83 and 57-44 respectively Smith et al 2021 According to another review although not life-threatening CIPN threatens function in children and adolescents treated for cancer both during and following treatment Bjornard et al 2018 Smith et al 2021 noted sensory and motor neuropathy pain and functional impairments are not uncommon and appear to continue into adulthood The most common CIPN symptoms in children and adolescents are numbness tingling neuropathic pain in the upper and lower limbs weakness loss of ankle dorsiflexion range of motion foot drop and impaired balance van de Velde et al 2017 Kandula et al 2016 Schouten et al 2020 van de Velde et al 2021 VCR is one of the most commonly used vinca alkaloids in pediatric cancer patients and is included in a variety of multiple chemotherapy treatments for acute lymphoblastic leukemia lymphomas neuroblastoma sarcomas and central nervous system tumors Mora et al 2016 Schouten et al 2020 Neurotoxicity as a prominent side effect of VCR defined by autonomic and peripheral sensory-motor neuropathy has been documented in three studies to be as low as 12 and as high as 87 of VCR-exposed children Gilchrist et al 2014 van de Velde et al 2017 van de Velde et al 2021 The fact that the prevalence of VIPN is so wide is due to the difference in the measurement tools used van de Velde et al 2017 VIPN symptoms generally arise after only a few VCR injections and symptoms often fade a few months after VCR medication is stopped Paresthesia constipation muscular weakness areflexia neuropathic pain and lack of sensation symptoms commonly relate to VIPN van de Velde et al 2021
VIPN treatment addresses symptoms and involves analgesics like gabapentin and amitriptyline van de Velde et al 2021 However the only successful therapy option for VIPN is VCR dosage reduction even though this limits optimal treatment Mora et al 2016 The limited treatment options for VIPN and the symptoms it causes in children have been linked to reducing the quality of life QoL both during and after treatment Mora et al 2016 Furthermore it is known that peripheral neuropathy pain affects QoL during cancer therapy However it is uncertain how much VIPN affects the QoL in children with cancer during therapy Bjornard et al 2018 van de Velde et al 2021
Many pharmacological and non-pharmacological methods are used in the management of peripheral neuropathy However the neurotoxicity mechanisms of peripheral neuropathy are not well known which a significant limitation in discovering effective treatments to prevent VIPN among pediatric oncology patients A systematic review focusing on the efficacy and safety of cryotherapy for preventing VIPN in adults reported that cryotherapy is a reasonable option to prevent VIPN Bailey et al 2021 The primary mechanism of benefit from cryotherapy has been hypothesized to be via vasoconstriction that decreases blood flow and therefore chemotherapy delivery to treated areas Loprinzi et al 2020 Unfortunately the following factors prevent the use of cryotherapy to prevent CIPN i rare reports of frostbite ii patient irritation iii administrative difficulties for patients parents and care professionals alike and iv the lack of conclusive evidence that this approach reduces CIPN Loprinzi et al 2020 Nevertheless many cryotherapy studies have shown the effectiveness of cryotherapy on peripheral neuropathy in adults Beijers et al 2020 Ng et al 2020 we were unable to identify any studies in children and adolescents with cancer There is a need for studies to evaluate the effectiveness of cryotherapy in reducing peripheral neuropathy in pediatric oncology patients This study aims to evaluate the effectiveness tolerability and acceptability of cold therapy on VIPN among pediatric oncology patients in Turkey
VIPN treatment addresses symptoms and involves analgesics like gabapentin and amitriptyline van de Velde et al 2021 However the only successful therapy option for VIPN is VCR dosage reduction even though this limits optimal treatment Mora et al 2016 The limited treatment options for VIPN and the symptoms it causes in children have been linked to reducing the quality of life QoL both during and after treatment Mora et al 2016 Furthermore it is known that peripheral neuropathy pain affects QoL during cancer therapy However it is uncertain how much VIPN affects the QoL in children with cancer during therapy Bjornard et al 2018 van de Velde et al 2021
Many pharmacological and non-pharmacological methods are used in the management of peripheral neuropathy However the neurotoxicity mechanisms of peripheral neuropathy are not well known which a significant limitation in discovering effective treatments to prevent VIPN among pediatric oncology patients A systematic review focusing on the efficacy and safety of cryotherapy for preventing VIPN in adults reported that cryotherapy is a reasonable option to prevent VIPN Bailey et al 2021 The primary mechanism of benefit from cryotherapy has been hypothesized to be via vasoconstriction that decreases blood flow and therefore chemotherapy delivery to treated areas Loprinzi et al 2020 Unfortunately the following factors prevent the use of cryotherapy to prevent CIPN i rare reports of frostbite ii patient irritation iii administrative difficulties for patients parents and care professionals alike and iv the lack of conclusive evidence that this approach reduces CIPN Loprinzi et al 2020 Nevertheless many cryotherapy studies have shown the effectiveness of cryotherapy on peripheral neuropathy in adults Beijers et al 2020 Ng et al 2020 we were unable to identify any studies in children and adolescents with cancer There is a need for studies to evaluate the effectiveness of cryotherapy in reducing peripheral neuropathy in pediatric oncology patients This study aims to evaluate the effectiveness tolerability and acceptability of cold therapy on VIPN among pediatric oncology patients in Turkey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None