CIPN - Chemotherapy-Induced Peripheral NeuropathyCIPNNCT05959811
Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
A study testing yoga in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer
- What is being tested?
- yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Aug 2023to 21 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese or Taiwanese-proficient men and women aged ≥18 years.
- Patients with stage I-III breast cancer.
- Suffering from peripheral neuropathy caused by chemotherapy (professional judgment by a physician).
- Willing to adhere to requirement that no new pain medication be taken throughout the study period.
- Willing to adhere to all study-related procedures, including randomization to one of the two arms.
- Patient answers "Yes" to at least one factor in the question: "Do participants think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?"
Who cannot join
- Metastatic disease.
- Drugs abuse such as amphetamines, morphine, etc.
- Pregnant
- Those with severe mental illness or mental instability who cannot cooperate with the trial.
- People who are severely hearing impaired, visually impaired, or demented and unable to perform yoga.
- Severe heart disease or chronic obstructive lung disease, liver or kidney failure,and edema or severe skin damage.
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- Severe spinal disease, affecting actors.
- Those who have participated in yoga practice in the past month.
- Those who do not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
Therefore, the aim of this study was to evaluate the efficacy of meridian yoga for CIPN in breast cancer patients. The investigators designed a clinical randomized controlled trial in which 80 patients with CIPN were equally divided into a control group (8 weeks of general care) and a treatment group (general care plus 16 times yoga interventions for 8 weeks). The assessment time was before (vision 1) and at the completion of 8 weeks of Meridian yoga treatment (vision 2). The primary outcome was the change in scores of the neuropathic pain scale (Chinese version). The secondary outcome was to the changes of meridian energy [Meridian Energy Analyzer (M.E.A.D.)], Perfusion Index (PI) value of peripheral blood flow, and the changes of cortisol and IL-6 level in salivary fluid.
- Being tested
- yoga
- Keywords
- yoga, CIPN, meridian energy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
60 minutes yoga practice ,twice a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| meridian yoga | Experimental | 60 minutes yoga ,twice a week for 8 weeks Receives: Other: yoga |
| usual care group | No intervention | 8 weeks of general care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Scale
The questionnaire explores the performance of patients with neuropathic pain and nociceptive pain in different pain types in this questionnaire, and has appropriate reliability and validity, among which, specific pain performance, for different types of pain and changes in nerve conduction examination have special performance.
This questionnaire is NPSI-T(Chinese version of neuropathic pain symptom inventory). It consists of 12 questions, all of which address pain on a scale of 0-10. Higher scores mean a worse outcome.
Measured: Change from baseline of Neuropathic Pain Scale at 8 weeks.
Secondary outcomes (1)
Peripheral perfusion index
The investigators expected to observe changes in peripheral perfusion values to reflect the correlation between peripheral blood flow and peripheral neuropathy.
The normal value of Peripheral perfusion index(PPI) was suggested to range between 0.2 and 20%.Higher Peripheral perfusion index values reflects better peripheral tissue perfusion.
Measured: Change from baseline Peripheral perfusion index at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start2 Aug 2023
- Primary completion6 Jun 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959811
- Sponsor's protocol ID
- CMUH112-REC3-077
- Acronym
- CIPN
- Status last verified
- Feb 2025
- First submitted
- 20 Jun 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05959811
- Acronym / sponsor ID
- CIPN / CMUH112-REC3-077
- Keywords
- yoga, CIPN, meridian energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 25 Jul 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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
Therefore, the aim of this study was to evaluate the efficacy of meridian yoga for CIPN in breast cancer patients. The investigators designed a clinical randomized controlled trial in which 80 patients with CIPN were equally divided into a control group (8 weeks of general care) and a treatment group (general care plus 16 times yoga interventions for 8 weeks). The assessment time was before (vision 1) and at the completion of 8 weeks of Meridian yoga treatment (vision 2). The primary outcome was the change in scores of the neuropathic pain scale (Chinese version). The secondary outcome was to the changes of meridian energy [Meridian Energy Analyzer (M.E.A.D.)], Perfusion Index (PI) value of peripheral blood flow, and the changes of cortisol and IL-6 level in salivary fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meridian yoga | Experimental | Other: yoga60 minutes yoga ,twice a week for 8 weeks |
| usual care group | No intervention | –8 weeks of general care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese or Taiwanese-proficient men and women aged ≥18 years.
- Patients with stage I-III breast cancer.
- Suffering from peripheral neuropathy caused by chemotherapy (professional judgment by a physician).
- Willing to adhere to requirement that no new pain medication be taken throughout the study period.
- Willing to adhere to all study-related procedures, including randomization to one of the two arms.
Key exclusion criteria (9 listed)
- Metastatic disease.
- Drugs abuse such as amphetamines, morphine, etc.
- Pregnant
- Those with severe mental illness or mental instability who cannot cooperate with the trial.
- People who are severely hearing impaired, visually impaired, or demented and unable to perform yoga.
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 |
|---|---|---|
| yoga60 minutes yoga practice ,twice a week for 8 weeks | Other | meridian yoga |
Primary outcome
Neuropathic Pain Scale
Time frame: Change from baseline of Neuropathic Pain Scale at 8 weeks.
The questionnaire explores the performance of patients with neuropathic pain and nociceptive pain in different pain types in this questionnaire, and has appropriate reliability and validity, among which, specific pain performance, for different types of pain and changes in nerve conduction examination have special performance. This questionnaire is NPSI-T(Chinese version of neuropathic pain symptom inventory). It consists of 12 questions, all of which address pain on a scale of 0-10. Higher scores mean a worse outcome.
1 secondary outcome
Peripheral perfusion index
Time frame: Change from baseline Peripheral perfusion index at 8 weeks.
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.
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 9 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 27 Feb 2025. 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 Taiwan. 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?
Neuropathic Pain Scale (time frame: Change from baseline of Neuropathic Pain Scale at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.