Acupuncture for Breast Cancer

Overseen By Hongjin Li, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Must be taking: Endocrine therapy

Disqualifiers: Psychiatric hospitalization, Bleeding disorder, others

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

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

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

Compensation: Varies

Number of Visits: 10

Duration: 5 weeks

48 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be currently receiving adjuvant endocrine therapy to participate.

What data supports the idea that Acupuncture for Breast Cancer is an effective treatment?

The available research shows that acupuncture can help reduce some side effects of hormone therapy in breast cancer patients, such as hot flashes, fatigue, and stiffness. One study found moderate improvements in these symptoms, although it noted that more large-scale research is needed. Another study reported significant improvements in symptoms like poor sleep, fatigue, and pain after acupuncture treatments. Overall, acupuncture appears to be a promising alternative treatment for managing certain side effects of breast cancer therapies. ^{1 2 3 4 5}

What safety data exists for acupuncture in breast cancer treatment?

Acupuncture is generally considered safe for breast cancer patients, with serious adverse events being rare. Mild adverse events such as bruising, pain, swelling, skin infection, hematoma, headache, and menstrual bleeding have been reported. Systematic reviews indicate that while acupuncture is effective for managing treatment-related symptoms, the safety data is often inadequately reported, and more rigorous trials are needed to confirm its safety and efficacy. ^{1 6 7 8 9}

Is acupuncture a promising treatment for breast cancer?

Yes, acupuncture is a promising treatment for breast cancer. It can help reduce side effects from hormone therapy and improve symptoms related to cancer treatments. Studies show it can be a helpful part of supportive care for breast cancer survivors. ^{1 2 5 10 11}

What is the purpose of this trial?

The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

Eligibility Criteria

This trial is for English-speaking women who finished primary breast cancer treatment (stages 0-III) at least 3 months ago but within the last 5 years, are on adjuvant endocrine therapy, and suffer from pain, fatigue, or sleep issues with a severity of ≥3. Excluded are those with recent psychiatric hospitalization, bleeding disorders, pregnancy or inability to complete study procedures.

Inclusion Criteria

I have experienced significant pain, fatigue, or sleep problems in the last three months.

I finished my main cancer treatment between 3 months and 5 years ago.

I have been diagnosed with early to mid-stage breast cancer.

Exclusion Criteria

I am unable to complete study tasks due to physical or mental reasons.

I have been hospitalized for a mental health issue in the last 2 years.

I have a condition that affects my blood's ability to clot.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture treatments twice weekly for 5 weeks

5 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Acupuncture

Trial Overview The study tests if acupuncture can alleviate psychoneurological symptoms like pain, fatigue, and sleep disturbances in breast cancer survivors. Participants will receive acupuncture treatments twice weekly over five weeks while researchers track changes in biomarkers.

Participant Groups

Group I: Acupuncture Experimental Treatment 1 Intervention

All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session.

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?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

Acupuncture may help reduce functional stiffness in breast cancer patients undergoing hormone therapy, based on a review of 17 randomized controlled trials involving 810 participants.

While acupuncture showed moderate effects on stiffness, it did not significantly alleviate other common side effects of hormone therapy, such as hot flashes and fatigue, indicating that its benefits may be limited to specific symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review. Pan, Y., Yang, K., Shi, X., et al.[2019]

A study involving 25 breast cancer survivors identified six key factors influencing their decision to participate in acupuncture clinical trials, including symptom appraisal, practical barriers, and beliefs about the treatment.

Both African-American and Caucasian participants considered similar factors, but they differed in their preferred information sources and concerns about placebo use, highlighting the need for tailored recruitment strategies in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. Schapira, MM., Mackenzie, ER., Lam, R., et al.[2022]

Acupuncture has been found to provide moderate relief from hormone therapy-related side effects such as hot flashes, fatigue, and stiffness in breast cancer patients, based on a systematic review of randomized controlled trials.

Despite these positive findings, the evidence quality was downgraded due to inconsistencies and imprecision in the studies, highlighting the need for larger, more standardized trials to confirm acupuncture's efficacy and explore its biological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for Hormone Therapy-Related Side Effects in Breast Cancer Patients: A GRADE-Assessed Systematic Review and Updated Meta-Analysis. Yuanqing, P., Yong, T., Haiqian, L., et al.[2022]

A study involving 375 cancer patients showed that outpatient acupuncture significantly reduced various symptoms related to cancer treatment, with the most notable improvements in hot flashes, fatigue, and nausea after the first treatment.

Patients experienced both immediate and lasting benefits from acupuncture, with significant reductions in overall distress and specific symptoms like spiritual pain, indicating acupuncture could be a valuable complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient acupuncture effects on patient self-reported symptoms in oncology care: a retrospective analysis. Lopez, G., Garcia, MK., Liu, W., et al.[2020]

A systematic review of 1228 articles identified only 8 observational studies and 1 randomized controlled trial (RCT) on the use of acupuncture for alleviating symptoms in breast cancer survivors, indicating limited high-quality evidence.

While the studies suggested that acupuncture may help with symptoms like lymphedema and chemotherapy-induced peripheral neuropathy, the overall lack of rigorous RCTs means that more comprehensive research is needed to confirm its efficacy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence of acupuncture for symptoms related to breast cancer survivors: A PRISMA-compliant systematic review of clinical studies in Korea. Kim, TH., Kang, JW., Lee, MS.[2021]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

Acupuncture is recognized as a safe and effective treatment for managing acute chemotherapy-induced nausea and vomiting in cancer patients, supported by recent clinical trials and research on its physiological mechanisms.

The growing acceptance of acupuncture in oncology settings highlights its role in supportive care, with many cancer clinics now recommending and administering this treatment to alleviate side effects from conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in the oncology setting: clinical trial update. Capodice, JL.[2021]

A systematic review of 115 Chinese-language articles identified 479 cases of adverse events related to acupuncture, with 14 reported deaths, highlighting significant safety concerns.

The most common adverse events included pneumothorax and infections, primarily resulting from improper techniques, indicating a need for improved monitoring and risk management in acupuncture practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. Zhang, J., Shang, H., Gao, X., et al.[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 has been shown to be a safe and effective treatment for various symptoms associated with cancer, including nausea, pain, fatigue, and insomnia, based on a systematic review of 23 clinical trials.

The evidence suggests that acupuncture can help minimize side effects from conventional cancer treatments, improving patients' overall quality of life during their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture techniques and acupoints used in individuals under chemotherapy or radiotherapy treatment of cancer: A systematic review. de Sousa, TR., Mattos, S., Marcon, G., et al.[2023]

The review highlights the effectiveness of acupuncture in managing symptoms related to cancer, based on a decade of research by the author's group.

Future investigations are suggested to explore new directions in the application of acupuncture for cancer symptom management, indicating ongoing interest and potential for this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture as cancer symptom therapy: what a difference a decade makes. Johnstone, PA.[2022]

References

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

Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. [2022]

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

Acupuncture for Hormone Therapy-Related Side Effects in Breast Cancer Patients: A GRADE-Assessed Systematic Review and Updated Meta-Analysis. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Outpatient acupuncture effects on patient self-reported symptoms in oncology care: a retrospective analysis. [2020]

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

Current evidence of acupuncture for symptoms related to breast cancer survivors: A PRISMA-compliant systematic review of clinical studies in Korea. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

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

Acupuncture in the oncology setting: clinical trial update. [2021]

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

Acupuncture-related adverse events: a systematic review of the Chinese literature. [2022]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Acupuncture techniques and acupoints used in individuals under chemotherapy or radiotherapy treatment of cancer: A systematic review. [2023]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Acupuncture as cancer symptom therapy: what a difference a decade makes. [2022]