Hand-Foot Exercises on Chemotheraphy Induced Peripheral Neuropathy Pain, Falls and Quality of Life in Colorectal Cancer

Sponsor

Gulhane Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05873829

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Peripheral Neuropathy Colorectal Cancer	Other: Hand-foot exercises	N/A

Detailed Description

Aim of the study:This 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 study:The 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 date:The 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 setting:The 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.

Measuraments:Research 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 considerations:Ethics 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 conducted.Verbal and written informed consent was obtained from the patients who agreed to participate in the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The patients, whose written and verbal consents were obtained in accordance with the inclusion criteria, were randomly assigned to the intervention and control groups. Hand-foot exercises were applied to the patients in the intervention group. The patients in the control group did not undergo any intervention other than standard care.The patients, whose written and verbal consents were obtained in accordance with the inclusion criteria, were randomly assigned to the intervention and control groups. Hand-foot exercises were applied to the patients in the intervention group. The patients in the control group did not undergo any intervention other than standard care.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Apr 25, 2022

Actual Primary Completion Date :

Jul 5, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Hand-foot exercises were applied to the intervention group.	Other: Hand-foot exercises Hand-foot exercise program consists of 5 hand and 5 foot exercises, and a total of 15 minutes of simple hand-foot exercises. The exercise program is applied 3 times a day, 3 days a week. The tennis ball and the towel that used in the exercise program, the booklet which containing the exercise explanations and the video link showing the implementation of the exercises were provided by the researcher.
No Intervention: Control Group No intervention other than standard care was applied to the control group.

Arm

Intervention/Treatment

Experimental: Intervention Group

Hand-foot exercises were applied to the intervention group.

Other: Hand-foot exercises

Hand-foot exercise program consists of 5 hand and 5 foot exercises, and a total of 15 minutes of simple hand-foot exercises. The exercise program is applied 3 times a day, 3 days a week. The tennis ball and the towel that used in the exercise program, the booklet which containing the exercise explanations and the video link showing the implementation of the exercises were provided by the researcher.

No Intervention: Control Group

No intervention other than standard care was applied to the control group.

Outcome Measures

Primary Outcome Measures

Chemotheraphy induced peripheral neuropaty related Pain Severity [0. week (begining of the study) - 8. week (end of the study)]
Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related pain severtiy- Numeric Pain Rating Scale
Chemotheraphy induced peripheral neuropaty related Falls [0. week (begining of the study) - 8. week (end of the study)]
Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related falls-Fall Follow-up Form
Colorectal cancer patient's Quality of Life [0. week (begining of the study) - 8. week (end of the study)]
Hand-foot exercise program effects on quality of life of patients-EORTC QLQ-C30, EORTC QLQ-CR29 scales
Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment [0. week (begining of the study) - 8. week (end of the study)]
Hand-foot exercise program effects on chemotheraphy induced peripheral neuropathy symptoms- CIPNAT tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Being 18 years or older.
Not having any physical or mental health problems that will prevent communication.
Being conscious and cooperative.
Being diagnosed with colorectal cancer.
Receiving 2, 3, 4, 5, 6 or 7 cycles of platinum-based chemotherapy.
Being treated with the FOLFOX regimen.
Having chemotherapy-induced peripheral neuropathy according to CIPNAT (Chemotherapy-Induced Peripheral Neuropathy Assessment Tool). (Answering "yes" to the first 4 questions)
Agree to participate in the research.

Exclusion Criteria:

Receiving less than 2 cycles of platinum-based therapy.
To be receiving platinum-based treatment at 8th cycle and above.
Being diagnosed with a chronic disease (diabetes) that can lead to peripheral neuropathy.
Experiencing neuropathic symptoms due to cervical or lumbar hernia.
Having a habit of using alcohol constantly.
Being on medication that masks neuropathy signs or may develop neuropathy symptoms. (Opioid, beta blocker, anticonvulsant, tricyclic antidepressant etc.)
Having previously received neurotoxic chemotherapy (such as taxane, vinca alkaloids, bortezomib).
To have had major surgery in the last 1 month.
Not having the physical and mental ability to complete the research.
Refusing to participate in the research. Drop out Criteria
Changing the chemotherapy protocol.
Not being able to apply the Hand-Foot Exercises Program regularly.
Indicate that they want to withdraw from the research while the research is in progress.
Not being reached while the research is in progress.
Losing life while research is in progress.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gülhane Training and Resarch Hospital	Ankara	Ankara/Keçiören	Turkey	06010

Sponsors and Collaborators

Gulhane Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

İlayda EROĞLU, Principal Researcher, Gulhane Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05873829

Other Study ID Numbers:

E-50687469-929-1800

First Posted:

May 24, 2023

Last Update Posted:

May 26, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by İlayda EROĞLU, Principal Researcher, Gulhane Training and Research Hospital

Colorectal cancer, Peripheral Neuropathies,Nursing

Additional relevant MeSH terms:

Colorectal Neoplasms

Peripheral Nervous System Diseases

Study Results

No Results Posted as of May 26, 2023