Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can prevent chemotherapy-induced peripheral neuropathy (nerve pain in the arms and legs) from worsening. Patients with breast cancer undergoing chemotherapy with the drug taxane often experience this painful side effect. The trial compares Traditional Chinese Medicine Acupuncture with a placebo version to determine the effectiveness of the real treatment. It seeks participants currently receiving taxane who have begun experiencing nerve pain. Volunteers should not be taking certain pain medications or have had recent acupuncture treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that acupuncture is safe for preventing chemotherapy-induced peripheral neuropathy?

Research has shown that acupuncture is generally safe for most people. Studies have found that acupuncture can help reduce pain for those experiencing nerve pain caused by cancer treatment. In some studies, participants reported feeling less pain after acupuncture sessions. However, not all studies found acupuncture effective in reducing nerve pain.

Importantly, acupuncture is usually well-tolerated, meaning people typically do not experience adverse side effects. So, even if it doesn't help everyone with nerve pain, it is unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chemotherapy-induced peripheral neuropathy, like medications, aim to manage symptoms with drugs such as pain relievers or antidepressants. But real acupuncture offers a non-drug approach, potentially reducing side effects. Researchers are excited about acupuncture because it might improve nerve function by stimulating specific points on the body, offering a more holistic method to help patients manage their symptoms. Additionally, this technique is non-invasive and generally well-tolerated, which could make it an appealing option for those seeking alternatives to pharmaceuticals.

What evidence suggests that this trial's treatments could be effective for TIPN?

This trial will compare the effects of real acupuncture with sham acupuncture for managing chemotherapy-induced peripheral neuropathy (CIPN). Research has shown that real acupuncture can help reduce pain and symptoms of CIPN, which is nerve damage from cancer treatment. One review of several studies found that real acupuncture significantly improved pain levels in patients with this condition. Another study found that real acupuncture not only reduced pain but also improved nerve function in patients with CIPN. Additionally, real acupuncture has relieved symptoms, especially pain, linked to CIPN. These findings suggest that real acupuncture could effectively manage symptoms of taxane-induced peripheral neuropathy during cancer treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7242803/

The Efficacy of Acupuncture in Chemotherapy-Induced ... Meta-analysis showed that acupuncture led to significant improvements in pain scores (−1.21, 95% confidence interval [CI] = −1.61 to −0.82, P < .00001) and ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1442841/full

Acupuncture in the treatment of chemotherapy-induced ... Conclusion: Acupuncture can improve the neuropathic pain intensity, the intensity of the CIPN, MCV of the median nerve, SCV of the tibial nerve and peroneal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925000068

Effects of acupuncture-related intervention on ... Acupuncture (with or without electrical stimulation) and TEAS reduced CIPN symptoms, particularly in relieving CIPN pain.

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01434-6/fulltext

Improving chemotherapy-induced peripheral neuropathy in ... The intervention group received a 16-week combined qigong and self-administered acupressure intervention. The primary outcome was self-reported ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06769061

The Use of Acupuncture to Reduce Chemotherapy Induced ... This is an exploratory trial to evaluate the feasibility and effectiveness of acupuncture in reducing CIPN in gynaecological cancer patients. Eligible patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6476456/

A systematic review of acupuncture for chemotherapy-induced ... Two studies found acupuncture to be effective in alleviating cipn pain and improving quality of life. One study found no benefit in improving neuropathic pain.

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.963358/full

The effectiveness and safety of acupuncture for ... Two studies revealed that, compared with placebo acupuncture, acupuncture does not reduce chemotherapy-induced neurotoxicity and functional disability (22, 23).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03582423

Acupuncture for Chemotherapy-induced Peripheral ... In this study, a 24-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of acupuncture for ...