Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Wanqing Iris Zhi, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anti-neuropathy medications

Disqualifiers: Pre-existing neuropathy, recent acupuncture, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.

Will I have to stop taking my current medications?

If you are currently taking anti-neuropathy medications like gabapentin, pregabalin, duloxetine, or glutamine, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of this treatment for chemotherapy-induced peripheral neuropathy?

Research suggests that acupuncture may help manage symptoms of chemotherapy-induced peripheral neuropathy, as several studies and reviews have evaluated its potential benefits and safety for this condition.

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Is acupuncture safe for treating chemotherapy-induced peripheral neuropathy?

Research studies have evaluated the safety of acupuncture for chemotherapy-induced peripheral neuropathy and generally found it to be safe for humans.

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How is acupuncture different from other treatments for chemotherapy-induced peripheral neuropathy?

Acupuncture is unique because it offers a non-drug approach to managing chemotherapy-induced peripheral neuropathy, which has few available treatment options. It involves stimulating specific points on the body with needles, and while it is widely used in some countries like South Korea, there is no standardized treatment for this condition yet.

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Eligibility Criteria

This trial is for English or Spanish-speaking adults over 18 with breast cancer, who are undergoing chemotherapy with taxane and have developed mild nerve pain (TIPN). They must be planning to continue this treatment and agree not to start new pain medications during the study. People can't join if they had neuropathy before starting chemo, are currently on anti-neuropathy meds, or used acupuncture recently.

Inclusion Criteria

I agree not to change my pain medication or its dose for the first 12 weeks of the study.

I have nerve pain from taxane treatment.

I have been diagnosed with invasive breast cancer.

Exclusion Criteria

I am currently taking medication for nerve pain.

I have not used acupuncture for symptom management in the last 28 days.

I have had nerve pain or tingling in my hands or feet within the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weekly visits for TIPN screening

Treatment

Participants receive weekly real or sham acupuncture treatment to prevent TIPN progression

Until taxane completion

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Participant Groups

The study tests whether real acupuncture can prevent worsening of nerve pain caused by taxane chemotherapy in breast cancer patients. Participants will receive either actual acupuncture (RA) or sham acupuncture (SA), which uses different needles and targets non-specific body areas.

Group I: real acupuncture (RA) Active Control 1 Intervention

Real Acupuncture weekly till taxane completion

Group II: sham acupuncture (SA) Placebo Group 1 Intervention

Sham Acupuncture weekly till taxane completion

Real Acupuncture is already approved in China, United States, European Union for the following indications:

🇨🇳 Approved in China as Acupuncture for:

• Pain relief
• Neuropathy management
• General wellness

🇺🇸 Approved in United States as Acupuncture for:

• Pain management
• Complementary therapy for various conditions

🇪🇺 Approved in European Union as Acupuncture for:

• Pain relief
• Complementary therapy for various conditions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Monmouth Middletown, NJ

Memorial Sloan Kettering Nassau Rockville Centre, NY

Memorial Sloan Kettering Basking Ridge Basking Ridge, NJ

Memorial Sloan Kettering Bergen Montvale, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Gateway for Cancer Research Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. [2022] To clinically evaluate the effectiveness of acupuncture when used in the management of chemotherapy-induced peripheral neuropathy (PN).

2. Germany pubmed.ncbi.nlm.nih.gov

An umbrella review of the evidence to guide decision-making in acupuncture therapies for chemotherapy-induced peripheral neuropathy. [2023] Acupuncture therapy is believed to have therapeutic potential for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). This umbrella review aims to summarize and evaluate the evidence from current systematic reviews/meta-analyses (SRs/MAs) on the effectiveness of acupuncture treatment for CIPN.

3. Brazil pubmed.ncbi.nlm.nih.gov

Acupuncture in adults with Chemotherapy-Induced Peripheral Neuropathy: a systematic review. [2020] to analyze and synthesize knowledge about the effect of acupuncture on chemotherapy-induced peripheral neuropathy symptoms in adults with cancer.

4. England pubmed.ncbi.nlm.nih.gov

Acupuncture and integrative oncology for taxane-induced peripheral neuropathy: a randomized multicentered study. [2023] To compare the effectiveness of acupuncture alone or with additional integrative oncology modalities for taxane-induced peripheral neuropathy-related symptoms in patients with gynecological and breast cancer.

5. Switzerland pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of acupuncture for chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. [2022] This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of acupuncture on chemotherapy-induced peripheral neuropathy (CIPN).

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Acupuncture against Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis. [2022] To determine the effectiveness and safety of acupuncture for chemotherapy-induced peripheral neuropathy. The review has been registered on the "PROSPERO" website; the registration number is CRD42020151654.

7. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. [2022] Some chemotherapy drugs can damage the nerves and cause peripheral neuropathy which is accompanied by severe neuropathic pain or gait impairment. The purpose of this study was to assess the feasibility and the safety of acupuncture for the treatment of peripheral neuropathy following chemotherapy in Korean breast cancer patients.

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy. [2020] Chemotherapy-induced peripheral neuropathy is a complex side effect with few available treatment options. The aim of the study was to test the effectiveness of an 8-week course of acupuncture in the management of chemotherapy-induced peripheral neuropathy in cancer patients who were receiving or had received neurotoxic chemotherapy.

9. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of the efficacy of acupuncture and electroacupuncture against chemotherapy-induced peripheral neuropathy. [2022] Chemotherapy-induced peripheral neuropathy (CIPN) occurs in 68.1% of patients within the first month of undergoing chemotherapy; however, standardized treatment for CIPN has not been established yet. The efficacy of acupuncture, a widely used treatment for CIPN in South Korea, has not been studied sufficiently. This study aimed to review the studies that evaluated the efficacy of acupuncture or electroacupuncture (EA) in treating CIPN.

10. United States pubmed.ncbi.nlm.nih.gov

Protocol for a systematic review and meta-analysis of the efficacy of acupuncture and electroacupuncture against chemotherapy-induced peripheral neuropathy. [2022] Chemotherapy-induced peripheral neuropathy (CIPN) occurs in approximately 30% to 40% of patients who receive chemotherapy; however, standardized treatment for CIPN has not yet been developed. Acupuncture is widely used to treat CIPN in Korea, but its efficacy has not been investigated. The purpose of this study is to review the current literature on the efficacy of acupuncture and electroacupuncture (EA) in treating CIPN.