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

Breast Cancer Clinical Trial

— CIPN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05959811
• Other study ID #: CMUH112-REC3-077
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: July 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 6, 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• yoga
60 minutes yoga practice ,twice a week for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary Cortisol level	Cortisol plays an important role in the energy metabolism, and is regarded as one of the main stress hormones.	Change from baseline Salivary cortisol level at 8 weeks.
Other	Interleukin-6(IL-6) level	The investigators suggest that Interleukin-6(IL-6) signaling may be an important biological mechanism associated with the persistence of painful CIPN symptoms	Change from baseline Salivary Interleukin-6(IL-6) level at 8 weeks.
Other	Meridian Energy Analyzer	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.	Change from baseline at 8 weeks.
Primary	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.	Change from baseline of Neuropathic Pain Scale at 8 weeks.
Secondary	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.	Change from baseline Peripheral perfusion index at 8 weeks.