Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

(PACT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Weidong Lu, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must be taking: Taxane chemotherapy

Disqualifiers: Cardiac disease, Seizure disorder, Neuropathy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether acupuncture or relaxation exercises can reduce symptoms like pain and numbness in breast cancer patients undergoing taxane-based chemotherapy. The goal is to improve their quality of life by alleviating these side effects. Acupuncture has been used to manage cancer pain and improve quality of life in cancer patients.

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 data supports the effectiveness of the treatment Acupuncture for Chemotherapy-Induced Peripheral Neuropathy?

Research shows that acupuncture, including traditional and electroacupuncture, may help manage symptoms of chemotherapy-induced peripheral neuropathy, a condition where nerves are damaged due to cancer treatment. Several studies and reviews suggest that acupuncture can be effective in reducing pain and improving nerve function in patients experiencing this side effect. ^{1 2 3 4 5}

Is acupuncture safe for treating chemotherapy-induced peripheral neuropathy?

Research suggests that acupuncture is generally safe for treating chemotherapy-induced peripheral neuropathy, with studies focusing on its feasibility and safety in patients. ^{4 6 7 8 9}

How does acupuncture differ from other treatments for chemotherapy-induced peripheral neuropathy?

Acupuncture is unique because it offers a non-drug approach to managing chemotherapy-induced peripheral neuropathy, a condition with few established treatments. It involves inserting thin needles into specific points on the body to potentially relieve symptoms, unlike other treatments that may rely on medications. ^{1 3 4 7 9}

Research Team

Weidong Lu, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Acupuncture (Behavioural Intervention)

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.

Participant Groups

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 China for the following indications:

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+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

The Comprehensive and Integrative Medicine Institute of South Korea

Collaborator

Trials

4

Recruited

220+

Findings from Research

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]

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]

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 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 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]

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]

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. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

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

Efficacy and Safety of Acupuncture against Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

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

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

Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. [2022]

7. 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]

8. Scotland 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). [2022]

9. 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]