Acupuncture for Breast Cancer Survivors

Overseen By Hongjin Li

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Illinois at Chicago

Must be taking: Endocrine therapy

Must not be taking: Psychotropic medication

Disqualifiers: Metastatic cancer, Bleeding disorders, 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: 10

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how acupuncture might assist women who have completed their main breast cancer treatments, such as surgery or chemotherapy, and are now experiencing issues like pain, fatigue, or sleep problems. Participants will receive acupuncture treatments twice a week for five weeks to determine if it can improve these symptoms. Women who have finished their primary treatment for stage 0 to III breast cancer in the past month and experience at least three of the following—pain, fatigue, sleep disturbance, depression, hot flashes, or anxiety—may be suitable for this study. As a Phase 1 trial, this research aims to understand how acupuncture works in people, offering participants the chance to be among the first to explore its potential benefits.

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

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

What prior data suggests that acupuncture is safe for breast cancer survivors?

Research has shown that acupuncture is generally safe for cancer patients, including breast cancer survivors. Studies indicate it is as safe as sham acupuncture and other treatments. Some mild side effects, such as pain, bruising, swelling, or headache, might occur, but serious issues are very rare.

A review of several studies found that acupuncture can help with joint pain caused by cancer treatment. This suggests it can be a reliable and safe option for managing certain symptoms. Overall, acupuncture appears well-tolerated and offers a low-risk treatment choice for breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer survivors, such as medication and physical therapy, acupuncture offers a non-invasive and holistic approach to managing symptoms. Researchers are excited about acupuncture because it aims to balance the body's energy, potentially reducing pain and fatigue without the side effects often associated with pharmaceuticals. This technique is distinct in its method of action: by stimulating specific points on the body, it may enhance overall well-being and provide relief more naturally.

What evidence suggests that acupuncture might be an effective treatment for breast cancer survivors?

Research has shown that acupuncture can benefit breast cancer survivors. A review of studies found that acupuncture might improve symptoms related to breast cancer treatment, such as pain, tiredness, and hot flashes. Many people report feeling better from acupuncture either immediately or after a few sessions. In this trial, participants in the acupuncture group will receive two acupuncture treatments each week for five weeks. Additionally, certain types of acupuncture, like electroacupuncture, have reduced long-term pain more effectively than standard care. These findings suggest that acupuncture may provide meaningful relief for symptoms experienced by breast cancer survivors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 18 who've had stage 0-III breast cancer, finished primary treatment within the last month, and are on endocrine therapy. They must have moderate to severe pain, fatigue, sleep issues, depression, hot flashes or anxiety. Excluded are those with bleeding disorders, inability to attend weekly acupuncture sessions, certain psychiatric or medical conditions that affect assessments (like dementia), and those pregnant or planning pregnancy.

Inclusion Criteria

I have been diagnosed with early-stage breast cancer.

I've had significant pain, fatigue, sleep issues, depression, hot flashes, or anxiety recently.

I finished my main cancer treatment last month and am now on hormone therapy.

Exclusion Criteria

I cannot commit to weekly acupuncture clinic visits.

I do not have any mental health or neurological conditions that could affect study results.

I have a bleeding disorder like hemophilia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 acupuncture treatments each week for 5 weeks, totaling 10 treatments

5 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Study Completion

Identify barriers and facilitators associated with implementing acupuncture

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture

Trial Overview

The study is examining how feasible it is to include acupuncture as a regular treatment in health centers for breast cancer survivors dealing with symptoms like pain and fatigue after their main cancer treatments have ended.

How Is the Trial Designed?

Group I: Acupuncture group Experimental Treatment 1 Intervention

Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.

Group II: Usual care group Active Control 1 Intervention

Participants will continue to receive their usual care.

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+

Published Research Related to This Trial

In a study of 48 women recovering from breast cancer surgery, both acupuncture combined with kinesiotherapy and kinesiotherapy alone significantly improved pain, upper limb function, and range of motion after 10 treatment sessions.

While both treatment groups showed improvements, there were no significant differences in outcomes between the two groups, indicating that kinesiotherapy alone may be as effective as adding acupuncture for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing breast cancer surgery. Giron, PS., Haddad, CA., Lopes de Almeida Rizzi, SK., et al.[2018]

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 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 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 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]

Breast cancer survivors commonly use Traditional Chinese Medicine (TCM) as a complementary approach to standard treatment, with 100% of participants utilizing acupuncture and many also using herbal medicine and dietary therapy to enhance their coping and manage side effects.

Participants reported various health benefits from TCM, including stress relief and a greater sense of control over their treatment journey, highlighting the importance of understanding their holistic needs for physical and psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Usage of Traditional Chinese Medicine for Breast Cancer-A Narrative Approach to the Experiences of Women with Breast Cancer in Australia-A Pilot Study. Porter, D., Cochrane, S., Zhu, X.[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]

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