China Medical University, Taiwan
Taichung, 404, Taiwan
NCT Number: NCT05959811
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.
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All sexes
Interventional
Not applicable
Taichung, 404, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 minutes yoga practice ,twice a week for 8 weeks
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.
Time frame: Change from baseline Peripheral perfusion index at 8 weeks.
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 Salivary cortisol level at 8 weeks.
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 Interleukin-6(IL-6) level at 8 weeks.
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 at 8 weeks.
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.
China Medical University Hospital
Other
Acronym: CIPN
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