Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN)

NCT ID: NCT04651907

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-06-30

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

acupuncture group

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 0.3mm×30mm. The needle placed for the real acupuncture group will be the same needle size as 0.3mm×30mm. 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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

use disposable sterile steel needles to insert to the acupuncture point

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.

Group Type: PLACEBO_COMPARATOR

minimal acupuncture

Intervention Type: OTHER

The sham-controlled group will be performed with minimal acupuncture (superficial needling) at non-acupoints.

waitlist-controlled group

As an waitlist control group, no acupuncture will be performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

use disposable sterile steel needles to insert to the acupuncture point

Intervention Type: OTHER

minimal acupuncture

The sham-controlled group will be performed with minimal acupuncture (superficial needling) at non-acupoints.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Hung Chen, Ph.D.

Role: STUDY_DIRECTOR

China Medical University, China

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Yu-Chen Lee, Ph.D.

Role: CONTACT

d5167@mail.cmuh.org.tw

886-4-22052121 ext. 1670

Facility Contacts

Yu-Chen Lee, Ph.D.

Role: primary

d5167@mail.cmuh.org.tw

+886-975-682-023

Other Identifiers

CMUH109-REC3-121

Identifier Type: -

Identifier Source: org_study_id