Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05873829
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2023-05-16
Brief Title:
Hand-Foot Exercises on Chemotheraphy Induced Peripheral Neuropathy Pain Falls and Quality of Life in Colorectal Cancer
Sponsor:
Gulhane Training and Research Hospital
Organization:
Gulhane Training and Research Hospital
Study Overview
Official Title:
The Effect of Hand-Foot Exercises on Platinum-Based Chemotheraphy Induced Peripheral Neuropathy Related Pain Severity Falls and Quality of Life in Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
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:
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
Detailed Description:
Aim of the studyThis study was conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity falls and quality of life in patients with colorectal cancer
Design of the studyThe research is a randomized controlled experimental study conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity falls and quality of life in patients with colorectal cancer
Study place and dateThe research was carried out in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit Research data were collected between 25 April and 31 December 2022
Sample and settingThe population of the study consists of patients diagnosed with colorectal cancer who received platinum-based treatment in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31 2022 The sample of the study consists of patients who were diagnosed with colorectal cancer in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31 2022 received at least 2 and maximum 7 cycles of platinum-based chemotherapy and accepted to participate in the study
MeasuramentsResearch data were collected with Sociodemographic and Clinical Characteristics Form Exercise Follow-up Form EORTC QLQ-C30 scale EORTC QLQ-CR29 scale Chemotherapy-Induced Peripheral Neuropathy Assessment Tool Numerical Pain Rating Scale Fall Status Follow-up Form
Ethical considerationsEthics committee approval was obtained from Ankara University Ethics Committee for the conduct of the study Institutional permission was obtained from Gülhane Training and Research Hospital the institution where the research was conductedVerbal and written informed consent was obtained from the patients who agreed to participate in the study
Design of the studyThe research is a randomized controlled experimental study conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity falls and quality of life in patients with colorectal cancer
Study place and dateThe research was carried out in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit Research data were collected between 25 April and 31 December 2022
Sample and settingThe population of the study consists of patients diagnosed with colorectal cancer who received platinum-based treatment in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31 2022 The sample of the study consists of patients who were diagnosed with colorectal cancer in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31 2022 received at least 2 and maximum 7 cycles of platinum-based chemotherapy and accepted to participate in the study
MeasuramentsResearch data were collected with Sociodemographic and Clinical Characteristics Form Exercise Follow-up Form EORTC QLQ-C30 scale EORTC QLQ-CR29 scale Chemotherapy-Induced Peripheral Neuropathy Assessment Tool Numerical Pain Rating Scale Fall Status Follow-up Form
Ethical considerationsEthics committee approval was obtained from Ankara University Ethics Committee for the conduct of the study Institutional permission was obtained from Gülhane Training and Research Hospital the institution where the research was conductedVerbal and written informed consent was obtained from the patients who agreed to participate in the study
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