84 Participants Needed

Acupuncture for Hot Flashes in Breast Cancer

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
Must be taking: Hormonal therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.13567

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.128910

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

WL

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.
See 4 more

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.
See 4 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate AcupunctureExperimental Treatment1 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 acupunctureActive Control1 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

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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

Impact of Acupuncture on Hot Flashes in Breast Cancer Patients Receiving Adjuvant Antiestrogen Therapy with Tamoxifen: A Randomized Controlled Trial. [2023]
Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). [2022]
Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial. [2023]
Long term follow up of breast cancer patients treated with acupuncture for hot flashes. [2020]
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]
Systematic review of acupuncture to control hot flashes in cancer patients. [2020]
Acupuncture for the treatment of hot flashes in patients with breast cancer receiving antiestrogen therapy: a pilot study in Korean women. [2022]
Effects of Acupuncture on Menopause-Related Symptoms in Breast Cancer Survivors: A Meta-analysis of Randomized Controlled Trials. [2017]
Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol. [2023]
Acupuncture for hot flashes in women with breast cancer: A systematic review. [2018]
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