Status:
UNKNOWN
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
China Medical University Hospital
Conditions:
Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the neurological efficacy of acupuncture in patients with cancer who experienced peripheral neuropathy, which is induced by chemotherapy.
Detailed Description
Background: Chemotherapy may lead to peripheral neuropathy up to 40% in cancer survivors, especially in some types of patients with cancer. The effect of acupuncture, an ancient Chinese medicine techn...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- The study will enroll patients with a symptom of peripheral neuropathy, including paresthesia, numbness, glove-and-stocking sensory loss distribution or pain in four limbs, and meet the following inclusion criteria:
- All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
- Stage I-III cancer patients
- Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
- Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
- Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
- Eastern Cooperative Oncology Group (ECOG) performance status ≦3
- Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
- Patients were restricted acupuncture treatment for one month before recruitment
- Written patient informed consent
- Exclusion criteria:
- Participants with any of the following conditions will be excluded:
- Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate\[19\].
- Diabetic neuropathy diagnosed before receiving chemotherapy
- Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
- Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
- Severe hemorrhagic coagulopathy or bleeding tendency
- Unstable cardiovascular disease
- Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.
Exclusion
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04739631
Start Date
January 22 2021
End Date
June 30 2022
Last Update
April 27 2021
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan