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

NCT04651907 | Unknown DMC

• 1 other identifier: CMUH109-REC3-121
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Keywords

acupuncture; chemotherapy-induced peripheral neuropathy; neuropathic pain; von-Frey monofilament test; taxane; platinum

Outcome Measures

Primary Outcomes (1)

• The change of FACT-Neurotoxicity subscale(NtxS)

  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.

  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 (2)

• The change of BPI-SF

  It will be assessed before the first session, after the 12th session, the 20th session, and followed at the end of the 12th week.

• The quantitative sensation of touch detection

  It will be assessed before the first session, the 20th session, and followed at the end of the 12th week.

Study Arms (3)

acupuncture group

EXPERIMENTAL

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.

Other: acupuncture

sham-controlled group

PLACEBO COMPARATOR

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.

Other: minimal acupuncture

waitlist-controlled group

NO INTERVENTION

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

Interventions

acupuncture OTHER

use disposable sterile steel needles to insert to the acupuncture point

acupuncture group

minimal acupuncture OTHER

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

sham-controlled group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yi-Hung Chen, Ph.D.

  China Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Yu-Chen Lee, Ph.D.

CONTACT

886-4-22052121; d5167@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: January 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)