Acupuncture for Breast Cancer Survivors

HL
Overseen ByHongjin Li, PhD, RN, FAAN
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: University of Illinois at Chicago
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how acupuncture can help breast cancer survivors manage common issues like pain, fatigue, and sleep problems. Participants will receive either real acupuncture, a version that mimics acupuncture without using the points, or continue their usual care. The goal is to determine if acupuncture can effectively improve these symptoms. Suitable candidates include breast cancer survivors who completed treatment at least three months ago, are currently on hormone therapy, and have recently experienced pain, fatigue, or sleep issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that acupuncture is likely to be safe for humans?

Research has shown that acupuncture is generally safe for breast cancer survivors. Studies have found that mild side effects, such as pain, bruising, or swelling, are uncommon. Acupuncture is considered as safe as sham acupuncture, a fake version where the needles do not penetrate the skin. This indicates that patients tolerate acupuncture well. Overall, it is regarded as a safe option for alleviating symptoms like pain and fatigue.12345

Why do researchers think this study treatment might be promising for breast cancer survivors?

Unlike traditional treatments for breast cancer survivors, which often include medications and therapies to manage symptoms, acupuncture offers a holistic approach by potentially alleviating pain and improving quality of life through natural means. Researchers are excited about acupuncture because it involves stimulating specific points on the body to promote healing and balance, without the need for drugs or invasive procedures. Additionally, acupuncture may provide relief with minimal side effects, making it an attractive option for those looking to complement their existing care routine.

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

Research has shown that acupuncture, which participants in this trial may receive, can help breast cancer survivors manage various symptoms. Studies have found that acupuncture significantly reduces pain, tiredness, and sleep issues compared to standard care alone. It also appears to alleviate hot flashes and enhance cognitive function, which refers to thinking and memory. Acupuncture is generally considered safe, with no serious side effects reported. Overall, evidence suggests acupuncture may improve the quality of life for breast cancer survivors.12367

Are You a Good Fit for This Trial?

This trial is for people who have survived breast cancer and are experiencing symptoms like pain, fatigue, or trouble sleeping. Participants should be adults who have completed their main cancer treatments.

Inclusion Criteria

I am 18 years old or older.
I am currently taking hormone therapy after my main cancer treatment.
Acupuncture-naïve
See 3 more

Exclusion Criteria

I am currently taking methylsulfonylmethane or glutathione supplements.
I am unable to physically or mentally complete the study procedures.
Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture or sham acupuncture treatments twice a week for 5 weeks

5 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks
Follow-up assessments at week 6, week 12, and week 24

What Are the Treatments Tested in This Trial?

Interventions

  • Acupuncture

Trial Overview

The study is testing whether acupuncture can help reduce pain, tiredness, and sleep problems in breast cancer survivors. Researchers will also look at how and why some people respond better to acupuncture than others.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Acupuncture groupExperimental Treatment1 Intervention
Group II: Usual care groupActive Control1 Intervention
Group III: Sham acupuncture groupPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

Acupuncture may ease breast cancer treatment side effects

In this analysis, acupuncture was more effective than untreated groups in reducing the intensity of pain, the severity of hot flashes and fatigue. They then ...

Efficacy and safety of acupuncture for the treatment ...

Acupuncture can partially alleviate insomnia symptoms in breast cancer patients. Moreover, acupuncture is safe and may serve as a dependable alternative therapy

Acupuncture improves breast cancer survivors' perceived ...

Real and sham acupuncture were more effective at improving breast cancer survivors' perceived cognitive impairment compared with usual care,

Acupuncture Improves Multiple Treatment-Related Symptoms ...

acupuncture significantly reduces multiple treatment-related symptoms compared with the usual care or waitlist control group among breast cancer survivors.

Acupuncture: Real-world patient-reported outcomes of ...

The purpose of this study was to evaluate real world perceived benefit of acupuncture for commonly experienced symptoms among breast cancer survivors. Methods: ...

Safety of acupuncture in oncology: A systematic review and ...

The current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients.

Efficacy and safety of acupuncture in the treatment ...

Overall, acupuncture is a safe and effective adjunctive therapy for CIPN in breast cancer patients, warranting further study to clarify its impact on objective