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

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand-foot exercises
Sponsored by
Gulhane Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Colorectal cancer, Peripheral Neuropathies,Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gülhane Training and Resarch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Hand-foot exercises were applied to the intervention group.

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

Outcomes

Primary Outcome Measures

Chemotheraphy induced peripheral neuropaty related Pain Severity
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
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
Hand-foot exercise program effects on quality of life of patients-EORTC QLQ-C30, EORTC QLQ-CR29 scales
Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment
Hand-foot exercise program effects on chemotheraphy induced peripheral neuropathy symptoms- CIPNAT tool

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
May 24, 2023
Sponsor
Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05873829
Brief Title
Hand-Foot Exercises on Chemotheraphy Induced Peripheral Neuropathy Pain, Falls and Quality of Life in Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer
Keywords
Colorectal cancer, Peripheral Neuropathies,Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Hand-foot exercises were applied to the intervention group.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention other than standard care was applied to the control group.
Intervention Type
Other
Intervention Name(s)
Hand-foot exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chemotheraphy induced peripheral neuropaty related Pain Severity
Description
Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related pain severtiy- Numeric Pain Rating Scale
Time Frame
0. week (begining of the study) - 8. week (end of the study)
Title
Chemotheraphy induced peripheral neuropaty related Falls
Description
Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related falls-Fall Follow-up Form
Time Frame
0. week (begining of the study) - 8. week (end of the study)
Title
Colorectal cancer patient's Quality of Life
Description
Hand-foot exercise program effects on quality of life of patients-EORTC QLQ-C30, EORTC QLQ-CR29 scales
Time Frame
0. week (begining of the study) - 8. week (end of the study)
Title
Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment
Description
Hand-foot exercise program effects on chemotheraphy induced peripheral neuropathy symptoms- CIPNAT tool
Time Frame
0. week (begining of the study) - 8. week (end of the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gülhane Training and Resarch Hospital
City
Ankara
State/Province
Ankara/Keçiören
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is not a plan to make individual participant data (IPD) available to other researchers.
IPD Sharing Access Criteria
Audiences of the research, pollsters, ethical committees and official authorities, researchers
Citations:
PubMed Identifier
25459280
Citation
Carozzi VA, Canta A, Chiorazzi A. Chemotherapy-induced peripheral neuropathy: What do we know about mechanisms? Neurosci Lett. 2015 Jun 2;596:90-107. doi: 10.1016/j.neulet.2014.10.014. Epub 2014 Oct 22. Erratum In: Neurosci Lett. 2015 Jun 2;596():108.
Results Reference
background
PubMed Identifier
25261162
Citation
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
Results Reference
background
PubMed Identifier
21242773
Citation
Tofthagen CS, McMillan SC, Kip KE. Development and psychometric evaluation of the chemotherapy-induced peripheral neuropathy assessment tool. Cancer Nurs. 2011 Jul-Aug;34(4):E10-20. doi: 10.1097/NCC.0b013e31820251de.
Results Reference
background
PubMed Identifier
31008843
Citation
Colvin LA. Chemotherapy-induced peripheral neuropathy: where are we now? Pain. 2019 May;160 Suppl 1(Suppl 1):S1-S10. doi: 10.1097/j.pain.0000000000001540.
Results Reference
background
PubMed Identifier
34655433
Citation
Burgess J, Ferdousi M, Gosal D, Boon C, Matsumoto K, Marshall A, Mak T, Marshall A, Frank B, Malik RA, Alam U. Chemotherapy-Induced Peripheral Neuropathy: Epidemiology, Pathomechanisms and Treatment. Oncol Ther. 2021 Dec;9(2):385-450. doi: 10.1007/s40487-021-00168-y. Epub 2021 Oct 16.
Results Reference
background
PubMed Identifier
27408692
Citation
Addington J, Freimer M. Chemotherapy-induced peripheral neuropathy: an update on the current understanding. F1000Res. 2016 Jun 22;5:F1000 Faculty Rev-1466. doi: 10.12688/f1000research.8053.1. eCollection 2016.
Results Reference
background
PubMed Identifier
19170681
Citation
Kaley TJ, Deangelis LM. Therapy of chemotherapy-induced peripheral neuropathy. Br J Haematol. 2009 Apr;145(1):3-14. doi: 10.1111/j.1365-2141.2008.07558.x. Epub 2009 Jan 16.
Results Reference
background
PubMed Identifier
27183099
Citation
Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
Results Reference
background
PubMed Identifier
21380613
Citation
Tofthagen C, Overcash J, Kip K. Falls in persons with chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2012 Mar;20(3):583-9. doi: 10.1007/s00520-011-1127-7. Epub 2011 Mar 5.
Results Reference
background
PubMed Identifier
21444285
Citation
Tofthagen C, McAllister RD, McMillan SC. Peripheral neuropathy in patients with colorectal cancer receiving oxaliplatin. Clin J Oncol Nurs. 2011 Apr;15(2):182-8. doi: 10.1188/11.CJON.182-188.
Results Reference
background
PubMed Identifier
17846553
Citation
Bakitas MA. Background noise: the experience of chemotherapy-induced peripheral neuropathy. Nurs Res. 2007 Sep-Oct;56(5):323-31. doi: 10.1097/01.NNR.0000289503.22414.79.
Results Reference
background
PubMed Identifier
30888982
Citation
Dhawan S, Andrews R, Kumar L, Wadhwa S, Shukla G. A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients. Cancer Nurs. 2020 Jul/Aug;43(4):269-280. doi: 10.1097/NCC.0000000000000693.
Results Reference
background
PubMed Identifier
29198853
Citation
Duregon F, Vendramin B, Bullo V, Gobbo S, Cugusi L, Di Blasio A, Neunhaeuserer D, Zaccaria M, Bergamin M, Ermolao A. Effects of exercise on cancer patients suffering chemotherapy-induced peripheral neuropathy undergoing treatment: A systematic review. Crit Rev Oncol Hematol. 2018 Jan;121:90-100. doi: 10.1016/j.critrevonc.2017.11.002. Epub 2017 Nov 7.
Results Reference
background
PubMed Identifier
31876991
Citation
Win MMTM, Fukai K, Nyunt HH, Linn KZ. Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. Nurs Health Sci. 2020 Jun;22(2):416-426. doi: 10.1111/nhs.12676. Epub 2019 Dec 26.
Results Reference
background

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

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