Electroacupuncture Therapy for Chronic Pain After Breast Cancer Treatment

Overseen By Kay Garcia, DRPH

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Metastatic cancer, Bleeding disorder, Pacemaker, others

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

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electroacupuncture therapy can reduce chronic pain in women who have undergone surgery for stage I-III breast cancer. Electroacupuncture uses small electrical currents through needles to target specific points in the skin, potentially easing pain and other post-surgery symptoms. Participants will join one of three groups: those receiving real electroacupuncture, those receiving a modified version (sham), and those receiving standard care without acupuncture. The trial seeks women who have been cancer-free but still experience persistent pain at least three months after their breast cancer treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

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

What prior data suggests that electroacupuncture therapy is safe for reducing chronic pain after breast cancer treatment?

Research has shown that electroacupuncture therapy is generally safe. Studies have not reported any serious side effects. Some individuals might experience mild side effects like bruising, but these are uncommon. This treatment has been used safely and effectively to help manage cancer-related pain. Overall, electroacupuncture is considered a low-risk option for managing long-term pain after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for chronic pain?

Researchers are excited about electroacupuncture therapy for managing chronic pain after breast cancer treatment because it offers a unique approach compared to standard options like medication and physical therapy. Unlike conventional painkillers, which often come with side effects, electroacupuncture uses electrical stimulation through acupuncture needles to potentially provide pain relief by targeting the body's natural pain-fighting mechanisms. This method is non-invasive and focuses on promoting the body's own healing processes, which might result in fewer side effects and enhance overall well-being. Additionally, the use of a sham electroacupuncture group in the study helps to determine the true efficacy of this therapy, offering the potential for a more robust understanding of its benefits.

What evidence suggests that electroacupuncture therapy might be an effective treatment for chronic pain after breast cancer treatment?

Research has shown that electroacupuncture therapy, which participants in this trial may receive, can effectively reduce chronic pain in cancer survivors. Studies have found that it reduces pain more than standard treatment without acupuncture, as experienced by participants in the waitlist control group of this trial. One study discovered that electroacupuncture significantly lowered pain levels and improved both physical and mental health for patients. These findings suggest that electroacupuncture could be a promising way to manage chronic pain after breast cancer surgery. ^{5 6 7 8 9}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult women over 18 who've had stage I-III breast cancer surgery and completed treatment at least 4 months ago. They must have chronic pain post-treatment, speak English, and be able to follow the study plan. Excluded are those with pacemakers, recent acupuncture treatments, bleeding disorders, or metastatic breast cancer.

Inclusion Criteria

You have seen a cancer doctor in the last 12 months.

You experience moderate to severe pain based on a pain assessment questionnaire called the Brief Pain Inventory.

Your recent blood tests show that you have enough white blood cells and platelets.

Exclusion Criteria

I am starting or planning to start a new lymphedema treatment.

I have used acupuncture for my current pain.

I have a history of bleeding disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electroacupuncture therapy or sham electroacupuncture therapy over 45 minutes 2-3 times per week for 4 weeks, or receive standard of care without acupuncture therapy

4 weeks

10 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroacupuncture Therapy

Trial Overview The trial tests if electroacupuncture can reduce chronic pain in patients after breast cancer surgery. It involves sending electrical pulses through needles into the skin. Participants will also undergo lab marker analysis and complete quality-of-life assessments.

How Is the Trial Designed?

Group I: Group I (electroacupuncture therapy) Experimental Treatment 4 Interventions

Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.

Group II: Group III (waitlist control) Active Control 3 Interventions

Patients receive standard of care without any kind of acupuncture therapy.

Group III: Group II (sham electroacupuncture therapy) Placebo Group 4 Interventions

Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 165 breast cancer survivors, electro-acupuncture (EA) significantly reduced pain severity more than battlefield auricular acupuncture (BFAA) at both 12 and 24 weeks, indicating EA may be a more effective treatment for chronic musculoskeletal pain.

Both EA and BFAA improved physical and mental health scores compared to usual care, suggesting that while EA is superior for pain relief, both methods are beneficial for overall well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electro-acupuncture versus battle field auricular acupuncture in breast cancer survivors with chronic musculoskeletal pain: subgroup analysis of a randomized clinical trial. Bao, T., Zhi, WI., Baser, RE., et al.[2023]

Acupuncture is highlighted as an important integrative therapy for managing chronic pain in cancer survivors, as recommended by the American Society of Clinical Oncology's recent guidelines.

The review focuses on randomized clinical trials showing acupuncture's effectiveness in treating specific pain conditions related to cancer treatment, such as chemotherapy-induced peripheral neuropathy and post-surgical pain, indicating its potential role in improving quality of life for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Acupuncture for Chronic Pain in Cancer Survivors: A Reflection on the American Society of Clinical Oncology Chronic Pain Guideline. Lu, W., Rosenthal, DS.[2022]

Acupuncture significantly reduces treatment-related symptoms such as pain intensity, fatigue, and hot flash severity in breast cancer survivors, based on a meta-analysis of 20 trials involving 1709 patients.

The treatment is generally safe, with only mild adverse events reported, but the studies had a high risk of bias, indicating a need for more rigorous trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. Li, H., Schlaeger, JM., Jang, MK., et al.[2022]

Acupuncture is recommended by the National Comprehensive Cancer Network as an effective integrative intervention for managing cancer pain, highlighting its role alongside pharmacological treatments.

The review provides specific acupuncture protocols for various cancer-related pain conditions, such as postoperative pain and chemotherapy-induced neuropathy, offering practical solutions for clinicians and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for cancer pain and related symptoms. Lu, W., Rosenthal, DS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218664/

Electro-acupuncture Versus Battle Field Auricular ... The PEACE trial demonstrated that electro-acupuncture (EA) and battle field auricular acupuncture (BFAA) both reduced pain more than usual care (UC) in cancer ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37612534/

subgroup analysis of a randomized clinical trial - PubMed - NIH Conclusion: EA was more effective than BFAA at reducing pain severity, but both similarly improved physical and mental health scores. Breast ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2777349

Effectiveness of Electroacupuncture or Auricular ... Electroacupuncture and auricular acupuncture are more effective than usual care at reducing chronic musculoskeletal pain in cancer survivors.

4. aacrjournals.org aacrjournals.org/cancerres/article/83/5_Supplement/PD8-05/716970

Abstract PD8-05: Effectiveness of Electroacupuncture Versus ... At week 24, the mean BPI pain severity was 2.84 (95% CI: 2.40, 3.28) in EA and 3.67 (95% CI: 3.23, 4.10) in AA. EA reduced pain severity ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213422024000209

How does pretreatment expectancy influence pain ... Evidence shows that acupuncture delivers clinically meaningful and durable pain reductions with minimal side effects when compared with usual care or analgesics ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1876382025000459

Acupuncture for chronic cancer pain: a systematic review ... Acupuncture for cancer-related pain appears safe and free of significant adverse reactions. Abstract. Introduction. Pain is highly prevalent among cancer ...

7. withpower.com withpower.com/trial/phase-3-breast-neoplasms-8-2016-6b7b5

Electroacupuncture Therapy for Chronic Pain After Breast ... Electroacupuncture therapy appears to be generally safe for humans, with no serious adverse events reported in studies. Some mild side effects like bruising, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225685/

Electroacupuncture for the treatment of cancer pain This paper aims to review the current evidence on electroacupuncture as an effective and safe therapy for cancer pain management.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558649/

The Therapeutic Effects of Acupuncture and ... A recent case report study demonstrated that acupuncture is an effective and safe therapeutic option for reducing cancer pain with minimal side-effects and ...