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Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients (CIPN)

Primary Purpose

CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
yoga
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CIPN - Chemotherapy-Induced Peripheral Neuropathy focused on measuring yoga, CIPN, meridian energy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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?" Exclusion Criteria: 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. Severe spinal disease, affecting actors. Those who have participated in yoga practice in the past month. Those who do not sign the informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    meridian yoga

    usual care group

    Arm Description

    60 minutes yoga ,twice a week for 8 weeks

    8 weeks of general care

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 20, 2023
    Last Updated
    July 25, 2023
    Sponsor
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05959811
    Brief Title
    Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
    Acronym
    CIPN
    Official Title
    Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 24, 2023 (Anticipated)
    Primary Completion Date
    June 6, 2024 (Anticipated)
    Study Completion Date
    June 6, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer
    Keywords
    yoga, CIPN, meridian energy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    meridian yoga
    Arm Type
    Experimental
    Arm Description
    60 minutes yoga ,twice a week for 8 weeks
    Arm Title
    usual care group
    Arm Type
    No Intervention
    Arm Description
    8 weeks of general care
    Intervention Type
    Other
    Intervention Name(s)
    yoga
    Intervention Description
    60 minutes yoga practice ,twice a week for 8 weeks
    Primary Outcome Measure Information:
    Title
    Neuropathic Pain Scale
    Description
    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.
    Time Frame
    Change from baseline of Neuropathic Pain Scale at 8 weeks.
    Secondary Outcome Measure Information:
    Title
    Peripheral perfusion index
    Description
    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.
    Time Frame
    Change from baseline Peripheral perfusion index at 8 weeks.
    Other Pre-specified Outcome Measures:
    Title
    Salivary Cortisol level
    Description
    Cortisol plays an important role in the energy metabolism, and is regarded as one of the main stress hormones.
    Time Frame
    Change from baseline Salivary cortisol level at 8 weeks.
    Title
    Interleukin-6(IL-6) level
    Description
    The investigators suggest that Interleukin-6(IL-6) signaling may be an important biological mechanism associated with the persistence of painful CIPN symptoms
    Time Frame
    Change from baseline Salivary Interleukin-6(IL-6) level at 8 weeks.
    Title
    Meridian Energy Analyzer
    Description
    The investigators use the Meridian Monitoring System test to detect changes in the conductivity of the skin on the surface of the meridians, in order to judge the changes in the energy of the mWeeridians of the body.
    Time Frame
    Change from baseline at 8 weeks.

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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?" Exclusion Criteria: 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. Severe spinal disease, affecting actors. Those who have participated in yoga practice in the past month. Those who do not sign the informed consent.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

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