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

NCT07693335 | Completed

• 1 other identifier: TMANH109-REC016
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This three-armed, multicenter, randomized, parallel, sham-controlled clinical trial will conduct in three centers in Taiwan. The investigators 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). 46 cases are expected to be received at Tainan Municipal Annan Hospital. Each subject maintain 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); Acupuncture

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) 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

  at baseline, at the end of 12th sessions(week 4), at the end of 20th sessions(week 8), at the week 12

Secondary Outcomes (2)

• the change of average pain severity in BPI-SF from baseline to 20 sessions at 8th weeks

  at baseline, at the end of 12th sessions(week 4), at the end of 20th sessions(week 8), at the week 12

• The quantitative sensation of touch detection

  at baseline, at the end of 20th sessions (week 8), at the week 12

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 than 3 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:

• \. 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

• Taiwan Municipal An-Nan Hospital-China Medical University: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• China Medical University Hospital: collaborator

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, 709, Taiwan

Location

Related Publications (3)

• Lu W, Giobbie-Hurder A, Freedman RA, Shin IH, Lin NU, Partridge AH, Rosenthal DS, Ligibel JA. Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial. Oncologist. 2020 Apr;25(4):310-318. doi: 10.1634/theoncologist.2019-0489. Epub 2019 Oct 14.

  PMID: 32297442 BACKGROUND

• Molassiotis A, Suen LKP, Cheng HL, Mok TSK, Lee SCY, Wang CH, Lee P, Leung H, Chan V, Lau TKH, Yeo W. A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419836501. doi: 10.1177/1534735419836501.

  PMID: 30905173 BACKGROUND

• D'Alessandro EG, Nebuloni Nagy DR, de Brito CMM, Almeida EPM, Battistella LR, Cecatto RB. Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study. BMJ Support Palliat Care. 2022 Mar;12(1):64-72. doi: 10.1136/bmjspcare-2018-001542. Epub 2019 Jun 29.

  PMID: 31256014 BACKGROUND

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, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After processing the baseline assessments and basic characteristic investigation, the study assistant randomly assigned eligible participants to each group. To ensure that the evaluations of participants will not be affected by knowledge of treatment assignment, the assessor will be blinded to the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, divisian of acupuncture, department of Chinese Medicine

Model Details: This three-armed, multicenter, randomized, parallel, sham-controlled clinical trial will conduct in three centers in Taiwan. The investigators 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 maintain 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.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: March 1, 2021
• Primary Completion: February 10, 2025
• Study Completion: June 30, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)