48 Participants Needed

Acupuncture for Breast Cancer

HL
Overseen ByHongjin Li, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.16789

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.1251011

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 β‰₯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.
See 1 more

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.
See 1 more

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
1Treatment groups
Experimental Treatment
Group I: AcupunctureExperimental Treatment1 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:

πŸ‡ΊπŸ‡Έ
Approved in United States as Acupuncture for:
  • Pain management
  • Hot flashes
  • Fatigue
  • Sleep disturbances
  • Anxiety
  • Depression
  • Neuropathy
πŸ‡ͺπŸ‡Ί
Approved in European Union as Acupuncture for:
  • Pain management
  • Hot flashes
  • Fatigue
  • Sleep disturbances
  • Anxiety
  • Depression
πŸ‡¨πŸ‡³
Approved in China as Acupuncture for:
  • Pain management
  • Hot flashes
  • Fatigue
  • Sleep disturbances
  • Anxiety
  • Depression
  • Neuropathy

Find a Clinic Near You

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.
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.
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.
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]

References

Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review. [2019]
Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. [2022]
Acupuncture for Hormone Therapy-Related Side Effects in Breast Cancer Patients: A GRADE-Assessed Systematic Review and Updated Meta-Analysis. [2022]
Outpatient acupuncture effects on patient self-reported symptoms in oncology care: a retrospective analysis. [2020]
Current evidence of acupuncture for symptoms related to breast cancer survivors: A PRISMA-compliant systematic review of clinical studies in Korea. [2021]
Safety of Acupuncture: Overview of Systematic Reviews. [2022]
Acupuncture in the oncology setting: clinical trial update. [2021]
Acupuncture-related adverse events: a systematic review of the Chinese literature. [2022]
Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]
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]
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