Clinical trial NCT05959811: Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Official title: Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Breast Cancer
Keywords: yoga
CIPN
meridian energy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Chinese or Taiwanese-proficient men and women aged ≥18 years.
2. Patients with stage I-III breast cancer.
3. Suffering from peripheral neuropathy caused by chemotherapy (professional judgment by a physician).
4. Willing to adhere to requirement that no new pain medication be taken throughout the study period.
5. Willing to adhere to all study-related procedures, including randomization to one of the two arms.
6. 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:

1. Metastatic disease.
2. Drugs abuse such as amphetamines, morphine, etc.
3. Pregnant
4. Those with severe mental illness or mental instability who cannot cooperate with the trial.
5. People who are severely hearing impaired, visually impaired, or demented and unable to perform yoga.
6. Severe heart disease or chronic obstructive lung disease, liver or kidney failure,and edema or severe skin damage.
7. Severe spinal disease, affecting actors.
8. Those who have participated in yoga practice in the past month.
9. Those who do not sign the informed consent.

Primary outcomes:
measure: Neuropathic Pain Scale
timeFrame: Change from baseline of Neuropathic Pain Scale at 8 weeks.
Secondary outcomes:
measure: Peripheral perfusion index
timeFrame: Change from baseline Peripheral perfusion index at 8 weeks.
Other outcomes:
measure: Salivary Cortisol level
timeFrame: Change from baseline Salivary cortisol level at 8 weeks.
measure: Interleukin-6(IL-6) level
timeFrame: Change from baseline Salivary Interleukin-6(IL-6) level at 8 weeks.
measure: Meridian Energy Analyzer
timeFrame: Change from baseline at 8 weeks.
Locations:
city: Taichung
country: Taiwan
facility: China Medical University, Taiwan
Study officials:
References: