Hand-Foot Exercises on Peripheral Neuropathy

NCT ID: NCT06055088

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-02-16

Brief Summary

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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

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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.

Conditions

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Breast Cancer Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Hand and foot exercise

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Hand and foot exercise

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hand and foot exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amasya University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neşe Uysal

Role: STUDY_DIRECTOR

Amasya U

Locations

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Health Science University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Uysal N, Unal Toprak F. The effect of hand and foot exercises on peripheral neuropathy and quality of life in women with breast cancer: a randomized controlled trial. Support Care Cancer. 2025 Jan 8;33(2):83. doi: 10.1007/s00520-025-09145-x.

Reference Type DERIVED
PMID: 39779496 (View on PubMed)

Other Identifiers

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AmasyaU-NU-678

Identifier Type: -

Identifier Source: org_study_id

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