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

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II trial studies how well electroacupuncture therapy works in reducing chronic pain in patients following surgery for stage I-III breast cancer. Electroacupuncture therapy is a type of complementary integrative medicine in which pulses of weak electrical current are sent through very thin, solid, sterile, stainless steel needles into certain points in the skin. Electroacupuncture therapy may help to lower pain and other surgery-related symptoms.

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.

Is electroacupuncture therapy safe for humans?

Electroacupuncture therapy appears to be generally safe for humans, with no serious adverse events reported in studies. Some mild side effects like bruising, pain, swelling, and skin infection have been noted, but they are not common. ^{1 2 3 4 5}

How does electroacupuncture therapy differ from other treatments for chronic pain after breast cancer treatment?

Electroacupuncture therapy is unique because it combines traditional acupuncture with electrical stimulation, which may help reduce chronic pain by modulating nerve activity and reducing inflammation. Unlike standard pain medications, it offers a non-drug approach that can also improve related symptoms like fatigue and sleep disturbances. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Electroacupuncture Therapy for chronic pain after breast cancer treatment?

Research shows that acupuncture, including electroacupuncture, is recommended for managing cancer-related pain and has been associated with reduced pain intensity and less need for pain medication in cancer survivors. ^{1 3 8 9 10}

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

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 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]

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]

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]

Citations

1. United States 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. [2022]

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

Acupuncture as a treatment modality for the management of cancer pain: the state of the science. [2012]

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

Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: a randomized trial. [2022]

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

Effectiveness of different acupuncture therapies for chronic cancer pain: A protocol for systematic review and Bayesian network meta-analysis. [2023]

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

Acupuncture for cancer pain and related symptoms. [2022]

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

Understanding the Benefits of Acupuncture Treatment for Cancer Pain Management. [2022]

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

Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Electroacupuncture for the treatment of cancer pain: a systematic review and meta-analysis of randomized clinical trials. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Electroacupuncture attenuates bone-cancer-induced hyperalgesia and inhibits spinal preprodynorphin expression in a rat model. [2021]

10. Netherlands 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. [2023]