Hand-Foot Exercises on Peripheral Neuropathy

NCT06055088 | Completed

• 1 other identifier: AmasyaU-NU-678
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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.

  8 week

• 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.

  8 week

• Visual Analog Scale (VAS)

  Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).

  8 week

Study Arms (3)

exercise with massage ball

EXPERIMENTAL

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.

Other: Hand and foot exercise

exercise with stress ball

EXPERIMENTAL

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

Other: Hand and foot exercise

control

NO INTERVENTION

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

Interventions

Hand and foot exercise 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 massage ball; exercise with stress ball

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Health Science University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39779496 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Neşe Uysal

  Amasya U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 26, 2023
• Study Start: June 1, 2023
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)