Clinical trial NCT06055088: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Neuropathy
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
timeFrame: 8 week
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ- CIPN 20)
timeFrame: 8 week
measure: Visual Analog Scale (VAS)
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Science University
Study officials:
affiliation: Amasya U
name: Neşe Uysal
role: STUDY_DIRECTOR
References: