Acupuncture for Hot Flashes in Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Hormonal therapy

Must not be taking: SSRIs, Anti-convulsants

Disqualifiers: Unstable cardiac disease, Seizure, Infection, 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: 30

Duration: 10 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You can continue taking your current medications for hot flashes if you've been on them for more than 4 weeks and keep the dose the same during the study. If you recently started a new medication for hot flashes, you might need to wait until you've been on it for at least 4 weeks before joining the study.

What data supports the effectiveness of acupuncture as a treatment for hot flashes in breast cancer patients?

Research shows that acupuncture significantly reduces the severity of hot flashes in breast cancer patients, improving their quality of life. Studies found that patients receiving acupuncture experienced a greater reduction in hot flash symptoms compared to those who did not receive treatment or received a placebo, with benefits lasting for weeks after treatment. ^{1 2 3 4 5}

Is acupuncture safe for treating hot flashes in breast cancer patients?

Research shows that acupuncture is generally safe for breast cancer patients experiencing hot flashes, with no adverse events reported in studies. ^{1 3 5 6 7}

How does acupuncture differ from other treatments for hot flashes in breast cancer patients?

Acupuncture is unique because it is a non-drug treatment that involves inserting thin needles into specific points on the body to help reduce hot flashes, unlike medications that may have side effects. It has been shown to improve the quality of life for breast cancer patients on tamoxifen without causing adverse effects. ^{1 2 8 9 10}

What is the purpose of this trial?

This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.

Research Team

Weidong Lu, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with Stage I-III hormone receptor-positive breast cancer who've finished primary treatment and are on hormonal therapy. They must have frequent hot flashes, be in good physical condition, and not planning further chemotherapy or surgery during the study.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I had Stage I-III breast cancer that was estrogen receptor and possibly HER2 positive.

I have been on hormone therapy for cancer, like Tamoxifen, for at least 4 weeks.

Exclusion Criteria

I have seizures that are not controlled by medication.

I am currently undergoing or planning to undergo treatment changes, including surgery or chemotherapy, during the study.

I started medication for hot flashes less than 4 weeks ago or have been on a stable dose for more than 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Immediate Acupuncture group receives acupuncture twice a week for 10 weeks; Delayed Acupuncture group receives usual care for 10 weeks

10 weeks

20 sessions for Immediate Acupuncture group, 0 sessions for Delayed Acupuncture group

Crossover Treatment

Delayed Acupuncture group receives acupuncture once a week for 10 weeks; Immediate Acupuncture group receives usual care for 10 weeks

10 weeks

10 sessions for Delayed Acupuncture group, 0 sessions for Immediate Acupuncture group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acupuncture

Trial Overview The study tests acupuncture as a potential remedy for reducing hot flashes against usual care without acupuncture. Participants will be randomly assigned to receive either acupuncture or their regular treatment to compare outcomes.

Participant Groups

Group I: Immediate Acupuncture Experimental Treatment 1 Intervention

* Will receive a standardized acupuncture protocol for a 10-week period * 20 sessions: twice a week for 10 weeks * After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.

Group II: Delayed acupuncture Active Control 1 Intervention

* Will receive standard usual care without acupuncture for 10 weeks * Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study

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?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

The Comprehensive and Integrative Medicine Institute of South Korea

Collaborator

Trials

4

Recruited

220+

References

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

Impact of Acupuncture on Hot Flashes in Breast Cancer Patients Receiving Adjuvant Antiestrogen Therapy with Tamoxifen: A Randomized Controlled Trial. [2023]

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

Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). [2022]

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

Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Long term follow up of breast cancer patients treated with acupuncture for hot flashes. [2020]

5. India pubmed.ncbi.nlm.nih.gov

Acupuncture for the relief of hot flashes in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials and observational studies. [2022]

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

Systematic review of acupuncture to control hot flashes in cancer patients. [2020]

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

Acupuncture for the treatment of hot flashes in patients with breast cancer receiving antiestrogen therapy: a pilot study in Korean women. [2022]

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

Effects of Acupuncture on Menopause-Related Symptoms in Breast Cancer Survivors: A Meta-analysis of Randomized Controlled Trials. [2017]

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

Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Acupuncture for hot flashes in women with breast cancer: A systematic review. [2018]