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

NCT ID: NCT05959811

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-12-21

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

meridian yoga

60 minutes yoga ,twice a week for 8 weeks

Group Type: EXPERIMENTAL

yoga

Intervention Type: OTHER

60 minutes yoga practice ,twice a week for 8 weeks

usual care group

8 weeks of general care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

yoga

60 minutes yoga practice ,twice a week for 8 weeks

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University, Taiwan

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH112-REC3-077

Identifier Type: -

Identifier Source: org_study_id