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Trial Title:
Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
NCT ID:
NCT05959811
Condition:
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Conditions: Keywords:
yoga
CIPN
meridian energy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
yoga
Description:
60 minutes yoga practice ,twice a week for 8 weeks
Arm group label:
meridian yoga
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.
Criteria for 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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 24, 2023
Completion date:
June 6, 2024
Lead sponsor:
Agency:
China Medical University Hospital
Agency class:
Other
Source:
China Medical University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05959811
