Hand-Foot Exercises on Peripheral Neuropathy
The Effect of Hand-Foot Exercises on Peripheral Neuropathy in Women With Breast Cancer Receiving Neurotoxic Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Health Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise with massage ball
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.
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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. |
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Experimental: exercise with stress ball
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
|
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. |
|
No Intervention: control
No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
Time Frame: 8 week
|
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.
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8 week
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European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ- CIPN 20)
Time Frame: 8 week
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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.
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8 week
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Visual Analog Scale (VAS)
Time Frame: 8 week
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Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).
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8 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neşe Uysal, Amasya U
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AmasyaU-NU-678
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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