Breast CancerNCT06055088
Hand-Foot Exercises on Peripheral Neuropathy
A study testing Hand and foot exercise in people with Breast Cancer and Neuropathy, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Neuropathy
- What is being tested?
- Hand and foot exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hand-Foot Exercises on Peripheral Neuropathy in Women With Breast Cancer Receiving Neurotoxic Chemotherapy
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
Read the 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.
- Conditions
- Breast Cancer, Neuropathy
- Being tested
- Hand and foot exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand and foot exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 week
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Jun 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neşe Uysal, Study director, Amasya U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055088
- Sponsor's protocol ID
- AmasyaU-NU-678
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39779496
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand-Foot Exercises on Peripheral Neuropathy in Women With Breast Cancer Receiving Neurotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT06055088
- Acronym / sponsor ID
- AmasyaU-NU-678
- Conditions
- Breast Cancer, Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise with massage ball | Experimental | Other: Hand and foot exerciseThe 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. |
| exercise with stress ball | Experimental | Other: Hand and foot exerciseThe 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 |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand and foot exerciseThe 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. | Other | exercise with massage ball, exercise with stress ball |
Primary outcome
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.
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
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)
Time frame: 8 week
Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39779496Uysal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neşe Uysal study director
Amasya U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand and foot exercise in people with Breast Cancer and Neuropathy, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0): (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.