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

62 Participants Needed

Trial Summary

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

The available research shows that acupuncture can significantly reduce symptoms like pain, fatigue, and hot flashes in breast cancer survivors. One study found that acupuncture was more effective than usual care in reducing these symptoms. Another study reported that patients experienced improvements in sleep, fatigue, and overall well-being after acupuncture sessions. These findings suggest that acupuncture can be a helpful treatment for managing symptoms in breast cancer survivors. ^{1 2 3 4 5}

What safety data exists for acupuncture in breast cancer survivors?

The systematic review and meta-analysis titled 'Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors' found that no serious adverse events were reported related to acupuncture. Mild adverse events such as bruising, pain, swelling, skin infection, hematoma, headache, and menstrual bleeding were reported in 11 studies. The safety of acupuncture was inadequately reported in the included studies, but it appears to be generally safe with some mild adverse events. ^{1 2 4 6 7}

Is acupuncture a promising treatment for breast cancer survivors?

Yes, acupuncture is a promising treatment for breast cancer survivors. It has been shown to help manage symptoms like pain, fatigue, and hot flashes, and improve overall well-being. Many breast cancer survivors have reported positive experiences with acupuncture as part of their recovery. ^{1 2 3 4 8}

What is the purpose of this trial?

The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. 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]

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

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

3. Switzerland 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. [2020]

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

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

5. Australia pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. 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]

8. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing breast cancer surgery. [2018]