Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

(PACT Trial)

Overseen By Weidong Lu, MB,MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Taxane chemotherapy

Disqualifiers: Cardiac disease, Seizure disorder, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether acupuncture can prevent or reduce symptoms of peripheral neuropathy—nerve damage causing pain, numbness, or tingling—caused by certain chemotherapy drugs. The focus is on improving the quality of life for breast cancer patients receiving taxane-based chemotherapy. Participants will either receive acupuncture treatments or watch nature videos with relaxation exercises. Ideal candidates are breast cancer patients scheduled for taxane-based chemotherapy who have not yet experienced neuropathy symptoms. As an unphased trial, this study provides participants the opportunity to explore alternative therapies that may enhance their quality of life during chemotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that acupuncture is generally well-tolerated by patients. One study found that acupuncture can help reduce pain caused by chemotherapy-induced peripheral neuropathy (CIPN), a type of nerve damage from chemotherapy that often results in pain, numbness, or tingling in the hands and feet. Additionally, acupuncture has been shown to improve the quality of life for patients undergoing chemotherapy.

Another review examined different types of acupuncture and their safety. It found that acupuncture, whether used alone or with other treatments like moxibustion (a therapy using heat), is safe for patients and usually does not cause serious side effects. Most people report only mild discomfort during the treatment, if any at all.

Overall, acupuncture is considered a safe treatment option for those experiencing CIPN from chemotherapy. Studies support its benefits in reducing pain and improving well-being without significant adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional treatments for chemotherapy-induced peripheral neuropathy that often rely on medications like gabapentin or duloxetine to manage symptoms, acupuncture offers a drug-free alternative. Researchers are excited about acupuncture because it uses a holistic approach, potentially reducing side effects associated with pharmaceuticals. Acupuncture's unique mechanism involves stimulating specific points on the body to promote natural healing and pain relief. This non-invasive treatment could offer relief to patients who prefer or require alternatives to medication-based therapies.

What evidence suggests that acupuncture might be an effective treatment for chemotherapy-induced peripheral neuropathy?

Research has shown that acupuncture might help with nerve pain caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). Some studies have found that acupuncture can reduce pain and improve the quality of life for people with CIPN. In this trial, participants in the acupuncture arm will receive a standardized acupuncture protocol. One study found that most patients felt much better after receiving acupuncture treatments. Reviews analyzing data from multiple studies have also confirmed the benefits of acupuncture for CIPN. Overall, the evidence suggests that acupuncture could effectively manage these uncomfortable side effects of chemotherapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Weidong Lu, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage I-III breast cancer, scheduled for taxane-based chemo without prior CIPN-inducing treatment or severe heart issues. They must have good performance status and no history of acupuncture use in the last 3 months.

Inclusion Criteria

I am about to start or have just started taxane-based chemotherapy for my cancer.

Signed informed consent

I am fully active or can carry out light work.

Exclusion Criteria

I have symptoms of nerve damage from chemotherapy.

I have a history of nerve damage in my hands or feet.

I have not had a heart attack or unstable heart condition in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acupuncture treatments or relaxation exercises during chemotherapy for 12 weeks

12 weeks

1-2 visits per week (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Questionnaire at 12 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture

Trial Overview The PACT Trial is testing if acupuncture can prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) compared to watching nature videos with relaxation exercises in patients receiving taxane-based chemotherapy.

How Is the Trial Designed?

Group I: Acupuncture Experimental Treatment 1 Intervention

* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 participants will be randomized into the acupuncture Arm: * The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).

Group II: Nature scenery videos with relaxation exercise Active Control 1 Intervention

* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 Participants will be randomized into the Control Arm: * The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

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

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

The Comprehensive and Integrative Medicine Institute of South Korea

Collaborator

Trials

4

Recruited

220+

Published Research Related to This Trial

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]

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]

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 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 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]

In a study involving 120 participants with chemotherapy-induced peripheral neuropathy (CIPN), a 10-week acupuncture treatment showed a significant improvement in symptoms, with 68% of those receiving acupuncture reporting a notable reduction in their symptoms compared to only 33% in the control group.

The study found no serious adverse events related to acupuncture, indicating it is a safe treatment option for managing CIPN symptoms, and the positive results suggest that further research is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, pragmatic clinical trial of ACUpuncture plus standard care versus standard care alone FOr Chemotherapy Induced peripheral Neuropathy (ACUFOCIN). Stringer, J., Ryder, WD., Mackereth, PA., 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39555482/

Acupuncture in the treatment of chemotherapy-induced ... This study aims to explore the specific efficacy and acupoint selection of acupuncture in treating CIPN through a meta-analysis and data mining.

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1527331/full

a dose-response meta-analysis of randomized controlled ... Some systematic reviews (7–9) have confirmed the efficacy of acupuncture in alleviating CIPN pain and improving quality of life.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0254627217300420

Effect of electroacupuncture on chemotherapy-induced ... After treatments, most patients with peripheral neuropathy were cured by two courses of electroacupuncture (84.2% vs 21.1%), whereas the other group of patients ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04739631

Study Details | NCT04739631 | Efficacy of Acupuncture on ... The purpose of this study is to assess the neurological efficacy of acupuncture in patients with cancer who experienced peripheral neuropathy, which is induced ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2020/2504674

Effectiveness of Acupuncture Treatment on Chemotherapy ... A systematic review and meta-analysis [29] revealed that acupuncture can effectively relieve CIPN pain and improve quality of life, whereas a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9574072/

A systematic review and meta-analysis - PMC Two studies revealed that, compared with placebo acupuncture, acupuncture does not reduce chemotherapy-induced neurotoxicity and functional disability (22, 23).

7. bmccomplementmedtherapies.biomedcentral.com bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-024-04603-1

Acupuncture-related interventions improve chemotherapy ... Acupuncture alone was most effective in reducing CIPN pain, and acupuncture plus moxibustion (acupuncture-M) ranked highest in enhancing QoL.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876382023000379

Network meta-analysis for comparative effectiveness and ... This study aims to evaluate the effectiveness and safety of different types of acupuncture through a systematic review and network meta-analysis.

9. e-jar.org e-jar.org/journal/view.html?pn=myread&uid=2677&vmd=Full

A Scoping Review of Clinical Trials Acupuncture demonstrates potential to prevent CIPN; however, there is limited pertinent data to guide protocols. This scoping review summarizes ...