Clinical trial NCT04651907: Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Official title: Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Keywords: acupuncture
chemotherapy-induced peripheral neuropathy
neuropathic pain
von-Frey monofilament test
taxane
platinum
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2020-12-03
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Methods: This three-armed, multicenter, randomized, parallel, sham-controlled clinical trial will conduct in three centers in Taiwan. We will randomly assign 234 eligible patients into three groups, an acupuncture group (n=90), a sham-controlled group (n=90), and a waitlist-controlled group (n=54). Each subject maintains the regular treatments of cancer except the chemotherapeutic agents designed in our design. 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 sham-controlled group will be performed with minimal acupuncture (superficial needling) at non-acupoints. The primary outcome measurement will be the changes in the FACT-Ntx subscale from baseline to 20th acupuncture sessions. The secondary outcome will be the changes in BPI-SF average pain score from baseline to 20th acupuncture sessions. The third outcome will be the changes of target forces by von-Frey filament test at each point in hands and feet from baseline to 20th acupuncture treatments. from baseline to 20th sessions. FACT-Ntx scale and BPI-SF average pain score will be measured at four time-points, including baseline, the end of the 12th treatments, the end of the 20th treatments, and the end of the study at the 12th week. The von-Frey filament test will be measured at three-time points, including baseline, the end of the 20th treatments, and the end of the study at the 12th week.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of FACT-Neurotoxicity subscale(NtxS)
timeFrame: It will be assessed before the first session, after the 12th session, the 20th session, and followed at the end of the 12th week.
Secondary outcomes:
measure: The change of BPI-SF
timeFrame: It will be assessed before the first session, after the 12th session, the 20th session, and followed at the end of the 12th week.
measure: The quantitative sensation of touch detection
timeFrame: It will be assessed before the first session, the 20th session, and followed at the end of the 12th week.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Yi-Hung Chen, Ph.D.
role: STUDY_DIRECTOR
References: