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

China Medical University

Status: Completed

Conditions: Breast Cancer; CIPN - Chemotherapy-Induced Peripheral Neuropathy

Treatments: Other: yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT05959811

CMUH112-REC3-077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

meridian yoga

Experimental group

Description:

60 minutes yoga ,twice a week for 8 weeks

Treatment:

Other: yoga

usual care group

No Intervention group

Description:

8 weeks of general care