Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy

Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial

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.

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 technique, was recognized by the World Health Organization (WHO) in the treatment of several diseases. The postulated mechanisms associated with acupuncture in analgesia or neurogenesis are still under investigation. Considering a moderate recommendation for duloxetine in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) based on based on neuropathic pain, and a few treatment options with evidence for CIPN, acupuncture might be another option. Nowadays, only small scale pilot studies provided initial proof of acupuncture in CIPN, particularly in decreasing neuropathic pain and improving neurotoxicity, the study aims to determine the beneficial effects of acupuncture on CIPN with a large-scale, multicenter, randomized sham-controlled clinical trial. Furthermore, the aim of the study will provide evidence for the clinical therapeutic guideline of CIPN in the future.

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:

1. All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
2. Stage I-III cancer patients
3. Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
4. Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
5. Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
6. Eastern Cooperative Oncology Group (ECOG) performance status ≦3
7. Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
8. Patients were restricted acupuncture treatment for one month before recruitment
9. Written patient informed consent

Exclusion criteria:

Participants with any of the following conditions will be excluded:

1. Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate[19].
2. Diabetic neuropathy diagnosed before receiving chemotherapy
3. Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
4. Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
5. Severe hemorrhagic coagulopathy or bleeding tendency
6. Unstable cardiovascular disease
7. Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.