Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT04739631

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• 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.

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 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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

use disposable sterile 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-control 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 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

China Medical University Hospital

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Fang-Pey Chen, Ph.D

Role: CONTACT

fpchen@vghtpe.gov.tw

886-2-28757453

Other Identifiers

2020-09-005C

Identifier Type: -

Identifier Source: org_study_id