Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Recruiting at 6 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anti-neuropathy medications

Disqualifiers: Pre-existing neuropathy, recent acupuncture, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Until taxane completion

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{2 6 8 9 10}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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)

Treatment Details

Interventions

• Real Acupuncture
• Sham Acupuncture

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Findings from Research

In a retrospective evaluation of 18 patients with chemotherapy-induced peripheral neuropathy, 82% reported symptom improvement after six weekly acupuncture sessions, suggesting acupuncture may be an effective management option.

Patients also experienced additional benefits such as reduced use of pain medication and improved sleep, indicating that acupuncture could enhance overall quality of life during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Donald, GK., Tobin, I., Stringer, J.[2022]

Acupuncture therapy shows potential benefits for patients with chemotherapy-induced peripheral neuropathy (CIPN), significantly improving pain symptoms and quality of life based on a review of 9 systematic reviews and meta-analyses involving 28 randomized controlled trials.

Despite the positive findings, the overall quality of the evidence was deemed unsatisfactory, indicating that while acupuncture may be effective and safe, caution is needed in interpreting these results due to methodological concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An umbrella review of the evidence to guide decision-making in acupuncture therapies for chemotherapy-induced peripheral neuropathy. Shi, H., Yuan, X., Fan, W., et al.[2023]

A systematic review of five studies indicates that acupuncture may improve symptoms of chemotherapy-induced peripheral neuropathy in adults with cancer, showing no reported side effects.

The studies varied in treatment protocols and outcome measures, highlighting the need for more standardized experimental research to strengthen the evidence for acupuncture's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in adults with Chemotherapy-Induced Peripheral Neuropathy: a systematic review. Baviera, AF., Olson, K., Paula, JM., et al.[2020]

In a study of 120 patients with gynecological and breast cancer, acupuncture alone significantly improved symptoms of foot numbness/tingling related to taxane-induced peripheral neuropathy after 6 weeks.

The combination of acupuncture with additional therapies showed greater improvements in emotional wellbeing and pain relief, indicating that multimodal approaches may enhance overall symptom management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and integrative oncology for taxane-induced peripheral neuropathy: a randomized multicentered study. Ben-Arye, E., Gamus, D., Samuels, N., et al.[2023]

Acupuncture has been found to significantly reduce pain severity and interference with daily functions in patients suffering from chemotherapy-induced peripheral neuropathy (CIPN), based on a systematic review of five studies.

While acupuncture showed improvements in quality of life compared to placebo, it did not significantly reduce overall neurotoxicity or CIPN symptoms, and no severe adverse events were reported, suggesting it is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of acupuncture for chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Xu, Z., Wang, X., Wu, Y., et al.[2022]

Acupuncture is an effective and safe treatment for chemotherapy-induced peripheral neuropathy (CIPN), as shown in a review of 19 randomized controlled trials involving 1174 patients, which demonstrated significant improvements in nerve conduction velocity and pain relief compared to medication and sham acupuncture.

The most commonly used acupuncture points for treating CIPN were LI4, LI11, ST36, EX10 (Bafeng), and EX-UE 9 (Baxie), indicating specific areas of focus that may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Acupuncture against Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis. Jin, Y., Wang, Y., Zhang, J., et al.[2022]

Acupuncture significantly reduced the severity of chemotherapy-induced peripheral neuropathy (CIPN) in Korean breast cancer patients, with 42.9% of participants showing improvement in sensory neuropathy after treatment.

The treatment also enhanced quality of life, as indicated by significant increases in SF-36 scores for physical functioning and general health perceptions, with effects lasting at least one month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. Jeong, YJ., Kwak, MA., Seo, JC., et al.[2022]

An 8-week course of acupuncture significantly reduced pain and improved quality of life in 87 cancer patients suffering from chemotherapy-induced peripheral neuropathy, compared to a wait-list control group.

The benefits of acupuncture were not only immediate but also sustained, with improvements in pain and quality of life lasting up to 20 weeks after treatment.

NCBI (Pubmed)

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. Molassiotis, A., Suen, LKP., Cheng, HL., et al.[2020]

Acupuncture has been found to be more effective than conventional pharmacological treatments for alleviating symptoms of chemotherapy-induced peripheral neuropathy (CIPN), based on a review of 13 studies involving 832 participants.

Despite the promising results, the overall quality of the studies was poor, and the specific efficacy of electroacupuncture compared to sham treatments remains unclear, making it difficult to definitively assess the effectiveness of acupuncture for CIPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of the efficacy of acupuncture and electroacupuncture against chemotherapy-induced peripheral neuropathy. Hwang, MS., Lee, HY., Choi, TY., et al.[2022]

Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of chemotherapy patients, and this study aims to evaluate the efficacy of acupuncture and electroacupuncture in treating its symptoms through a systematic literature review.

The review will include randomized controlled trials and assess pain relief using visual analog and numeric rating scales, with plans for a meta-analysis to summarize the findings and evaluate the risk of bias in the studies.

NCBI (Pubmed)

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. Hwang, MS., Lee, HY., Lee, JH., et al.[2022]

References

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

Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. [2022]

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]

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

Acupuncture in adults with Chemotherapy-Induced Peripheral Neuropathy: a systematic review. [2020]

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

Acupuncture and integrative oncology for taxane-induced peripheral neuropathy: a randomized multicentered study. [2023]

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]

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]

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]

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]

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]

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]