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Hand-Foot Exercises on Peripheral Neuropathy

Primary Purpose

Breast Cancer, Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand and foot exercise
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: The age of 18-80 years Clinical diagnosis of breast cancer Must be able to read and speak Turkish Must be the first time the taxane group receives chemotherapy Must be have at least grade 1 neuropathy according to CTCAE Must agree to participate in the study Exclusion Criteria: Presence of peripheral neuropathy conditions not caused by chemotherapy [tumor compression, nutritional disorders, infections, neurological diseases such as stroke, diabetes, etc.] Skin infection, scar tissue, inflammation, or cuts on the hands or feet Neuropsychiatric disease

Sites / Locations

  • Health Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

exercise with massage ball

exercise with stress ball

control

Arm Description

The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the massage ball group will be given a massage ball to be used in exercises.

The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the stress ball group will be given a stress ball to be used in exercises

No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied.

Outcomes

Primary Outcome Measures

National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
NCI-CTCAE v.5.0 publishes standardized definitions for known adverse events and defines the severity of organ toxicities for patients receiving cancer treatment. In NCI-CTCAE, the severity of chemotherapy-related peripheral neuropathy is divided into two: motor and sensory peripheral neuropathy, and the severity of complaints that interfere with patients' daily life and personal care is questioned.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ- CIPN 20)
It reveals the effects of chemotherapy-related peripheral neuropathy symptoms and the functional limitations caused by these symptoms on patients. The scale includes sensory (tingling, numbness, pain, unsteadiness when walking or standing, distinguishing temperature and hearing), motor (cramps, writing, grasping small objects, weakness) and autonomic (dizziness after changing position, vision, erectile dysfunction). It has 3 subscales: The 20 items in the scale are Likert type and the answers are evaluated by giving 1 point at all, 2 a little bit, 3 points a lot, 4 points a lot. High scores from these sections indicate more symptoms and problems, and low scores indicate fewer symptoms and problems.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).

Secondary Outcome Measures

Full Information

First Posted
September 17, 2023
Last Updated
September 23, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT06055088
Brief Title
Hand-Foot Exercises on Peripheral Neuropathy
Official Title
The Effect of Hand-Foot Exercises on Peripheral Neuropathy in Women With Breast Cancer Receiving Neurotoxic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
February 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amasya University

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
This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes
Detailed Description
İntroduction: New evaluation and care strategies for symptom control are gaining importance due to the increasing prevalence of cancer, expansion of chemotherapy indications, and the development of new chemotherapeutic agents with side effects such as peripheral neuropathy and pain. In the literature review, although there are studies evaluating the effects of neuropathic pain, neuropathy on quality of life and daily living activities, it was determined that there are a very limited number of studies on reducing chemotherapy-induced neuropathy. Simple, at-home exercises to prevent neuropathy can be done daily in a short period of time and do not require special equipment. These exercises may serve as an alternative therapy to improve quality of life by reducing pain in people with neuropathy. Purpose: This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes. Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 84 women with breast cancer receiving chemotherapy in the chemotherapy unit of a training and research hospital. Research data will be collected using the Introductory Information Form, Visual Analog Questionnaire (VAS), National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) -Peripheral Neuropathy, EORTC QLQ-CIPN 20. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. Data will be collected in two time periods: the week of starting exercise (T1) and the 8th week after exercise (T2). Conclusion: It is thought that home-based, simple exercise practices will reduce neuropathy symptoms and improve the quality of life in women with breast cancer receiving neurotoxic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise with massage ball
Arm Type
Experimental
Arm Description
The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the massage ball group will be given a massage ball to be used in exercises.
Arm Title
exercise with stress ball
Arm Type
Experimental
Arm Description
The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the stress ball group will be given a stress ball to be used in exercises
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied.
Intervention Type
Other
Intervention Name(s)
Hand and foot exercise
Intervention Description
The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. Patients in the massage ball group will be given a massage ball to be used in exercises. Patients in the stress ball group will be given a stress ball to be used in exercises.
Primary Outcome Measure Information:
Title
National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
Description
NCI-CTCAE v.5.0 publishes standardized definitions for known adverse events and defines the severity of organ toxicities for patients receiving cancer treatment. In NCI-CTCAE, the severity of chemotherapy-related peripheral neuropathy is divided into two: motor and sensory peripheral neuropathy, and the severity of complaints that interfere with patients' daily life and personal care is questioned.
Time Frame
8 week
Title
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ- CIPN 20)
Description
It reveals the effects of chemotherapy-related peripheral neuropathy symptoms and the functional limitations caused by these symptoms on patients. The scale includes sensory (tingling, numbness, pain, unsteadiness when walking or standing, distinguishing temperature and hearing), motor (cramps, writing, grasping small objects, weakness) and autonomic (dizziness after changing position, vision, erectile dysfunction). It has 3 subscales: The 20 items in the scale are Likert type and the answers are evaluated by giving 1 point at all, 2 a little bit, 3 points a lot, 4 points a lot. High scores from these sections indicate more symptoms and problems, and low scores indicate fewer symptoms and problems.
Time Frame
8 week
Title
Visual Analog Scale (VAS)
Description
Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).
Time Frame
8 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age of 18-80 years Clinical diagnosis of breast cancer Must be able to read and speak Turkish Must be the first time the taxane group receives chemotherapy Must be have at least grade 1 neuropathy according to CTCAE Must agree to participate in the study Exclusion Criteria: Presence of peripheral neuropathy conditions not caused by chemotherapy [tumor compression, nutritional disorders, infections, neurological diseases such as stroke, diabetes, etc.] Skin infection, scar tissue, inflammation, or cuts on the hands or feet Neuropsychiatric disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neşe Uysal
Phone
(90)3582181767
Email
nese.uysal@amasya.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neşe Uysal
Organizational Affiliation
Amasya U
Official's Role
Study Director
Facility Information:
Facility Name
Health Science University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neşe Uysal

12. IPD Sharing Statement

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Hand-Foot Exercises on Peripheral Neuropathy

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