Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- FACT-Neurotoxicity subscale(NtxS)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
acupuncture group
The acupuncture group and the sham-controlled group will receive three therapeutic sessions each week for four weeks, and another two sessions each week for four weeks (a total of 20 sessions at eight weeks). Each group will be followed-up for four weeks, to evaluate the persistent efficacy of acupuncture.The needle set for the sham acupuncture group and the real acupuncture group will use the CASOON Acupuncture Needle (Wuxi Jiajian Medical Instrument Company, limited), which needle size is 0.3 mm×30 mm. The depth of needling varied based on the patient's body sizes. After insertion, the needles were manually manipulated to obtain the De Qi sensation, which was defined as the acupuncturist feeling a tugging or grasping sensation from the needle manipulation and the patient feeling soreness, fullness, heaviness, or local distension at local needling sites.
Intervention: acupuncture (Other)
sham-controlled group
The sham acupuncture group will be performed by superficial needling with less than 4mm depth. The needling location is about 0.5 cm away from the acupoints. Both the real acupuncture group and the sham acupuncture group received the same treatment protocol.
Intervention: minimal acupuncture (Other)
waitlist-control group
As an waitlist-control group, no acupuncture will be performed.
Outcomes
Primary Outcomes
FACT-Neurotoxicity subscale(NtxS)
Time Frame: It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
The primary outcome will be the change FACT-Neurotoxicity subscale(NtxS) from baseline to 20 sessions at 8th weeks. The neurotoxicity subscale from the FACT/GOG-NTX-13(version 4) contains 13 items assessing numbness, tingling, and discomfort in the hands or feet, difficulty hearing, tinnitus, joint pain or muscle cramps, weakness, or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0-4 (0 = not at all; 4 = very much) and summed (total score range = 0-52). Since no published data are defining a cut-point for determining a clinically important change in the FACT/GOG Ntx score, we defined a 4 point change as a clinically meaningful improvement in patient-reported CIPN-related neurotoxicity outcome . The authorized translated traditional Chinese version will be purchased in this study.
Secondary Outcomes
- The change of BPI-SF(It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.)
- The quantitative sensation of touch detection(It will be assessed before the first intervention in the first week, after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.)