Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy

NCT06858709 | Recruiting

• 1 other identifier: ZNYYKL2025013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN); Cancer

Keywords

Chemotherapy-induced peripheral neuropathy (CIPN); electroacupuncture treatment

Outcome Measures

Primary Outcomes (1)

• Difference of the CIPN grade from baseline to week 6 after baseline

  The primary outcome will be the proportion of patients whose CIPN grade improved after the completion of 8 acupuncture treatments sessions.

  From enrollment to week 6

Secondary Outcomes (1)

• Changes in FACT/NTX subscale baseline to 6 weeks

  baseline,week 3, week6

Study Arms (2)

True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment

EXPERIMENTAL

Procedure: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment

Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment

PLACEBO COMPARATOR

Procedure: Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment

Interventions

True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment PROCEDURE

Participants will receive a total of 8 treatments over 6 weeks, with twice a week treatments for the first and the forth weeks and weekly treatment for the remaining weeks.The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. In the meantime, participants will receive the same standard anti-CIPN treatments.

True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment

Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment PROCEDURE

The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. In the meantime, participants will receive the same standard anti-CIPN treatments.

Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment

Eligibility Criteria

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

You may qualify if:

• years of age or older, of any nationality.
• Patients diagnosed with malignant tumor.
• Eligible patients will report altered sensations and/or pain and/or other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).
• Predicted life expectancy of ≥3 months.
• Intact skin without any breaches or purulent discharge.
• Written informed consent by the patient before enrolment Patients must be able to comply with the study protocol, which includes attending the treatment sessions on time and completing the study questionnaires in accordance with the study protocol.

You may not qualify if:

• History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.
• Patients with skin damage, pus or scar at the acupuncture stimulation area.
• Patients who are pregnant or breastfeeding.
• Significant mental conditions.
• Patients receiving other acupuncture treatments during the trial.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Haijun Yu

CONTACT

+86 67811727; haijunyu@whu.edu.cn

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: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)