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

NCT05959811 | Completed DMC

• 1 other identifier: CMUH112-REC3-077
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy; Breast Cancer

Keywords

yoga; CIPN; meridian energy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Peripheral perfusion index

  Change from baseline Peripheral perfusion index at 8 weeks.

Other Outcomes (3)

• Salivary Cortisol level

  Change from baseline Salivary cortisol level at 8 weeks.

• Interleukin-6(IL-6) level

  Change from baseline Salivary Interleukin-6(IL-6) level at 8 weeks.

• Meridian Energy Analyzer

  Change from baseline at 8 weeks.

Study Arms (2)

meridian yoga

EXPERIMENTAL

60 minutes yoga ,twice a week for 8 weeks

Other: yoga

usual care group

NO INTERVENTION

8 weeks of general care

Interventions

yoga OTHER

60 minutes yoga practice ,twice a week for 8 weeks

meridian yoga

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University, Taiwan

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 25, 2023
• Study Start: August 2, 2023
• Primary Completion: June 6, 2024
• Study Completion: December 21, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)