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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can reduce hot flashes in individuals with a history of breast cancer. Acupuncture involves inserting thin needles into specific body points to aid natural healing. Two groups will be tested: one receives immediate acupuncture twice a week for 10 weeks, while the other starts with usual care and switches to weekly acupuncture after 10 weeks. The trial seeks participants with breast cancer who experience frequent hot flashes, at least two per day, while on hormonal therapy. As an unphased trial, it offers participants the opportunity to explore a non-drug treatment option for managing hot flashes.

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 prior data suggests that acupuncture is safe for reducing hot flashes in breast cancer patients?

Research has shown that acupuncture is generally safe for treating symptoms like hot flashes. In past studies involving over 150 women, acupuncture proved to be a safe method for managing menopause-related symptoms. A 2018 review of 12 studies found acupuncture more effective than no treatment for certain types of pain, supporting its safety. These studies reported no serious side effects, suggesting that acupuncture is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for managing hot flashes in breast cancer patients because it offers a unique, drug-free alternative to traditional hormone therapies like estrogen replacement or medications such as gabapentin and clonidine. Acupuncture works by inserting thin needles into specific points on the body, which may help regulate body temperature and reduce the frequency and severity of hot flashes. This approach is particularly appealing for breast cancer patients who often seek non-hormonal options to avoid potential interactions or side effects with their ongoing cancer treatments. By providing a holistic and non-invasive method, acupuncture could offer a natural way to manage symptoms, enhancing the quality of life for these patients.

What evidence suggests that acupuncture might be an effective treatment for hot flashes?

Research has shown that acupuncture might help reduce hot flashes in people with breast cancer. Some studies have found that acupuncture can significantly improve hot flashes and related symptoms. In this trial, participants will be divided into two groups: one will receive immediate acupuncture treatments, while the other will initially receive standard care without acupuncture, followed by delayed acupuncture treatments. Patients in these studies reported fewer hot flashes and improved quality of life after acupuncture treatments. Acupuncture may also help with other symptoms like tiredness and pain from breast cancer treatments. While more research is needed to confirm these benefits, current evidence is promising. ^{6 7 8 9 10}

Who Is on the Research Team?

Weidong Lu, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11955814/

How effective is acupuncture in treating hot flashes in breast ... Although acupuncture treatment for hot flashes in breast cancer shows potential, the evidence for the efficacy of acupuncture is still lacking.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002117

Acupuncture for hot flashes in hormone receptor-positive ... Acupuncture has been reported to reduce hot flashes in patients with breast cancer undergoing adjuvant hormonal therapy.

3. mrctcenter.org mrctcenter.org/wp-content/uploads/2024/06/Cancer-2024-Lu-Acupuncture-for-hot-flashes-in-hormone-receptor%E2%80%90positive-breast-cancer-A-pooled-analysis-of.pdf

Acupuncture for hot flashes in hormone receptor‐positive ... Conclusions: Acupuncture led to statistically and clinically meaningful improve- ments in hot flashes, endocrine symptoms, and breast cancer‐ ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.646315/full

Acupuncture for Breast Cancer: A Systematic Review and ... Conclusions: Current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.12124

Acupuncture for hot flashes in hormone receptor-positive ... Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4066294/

Acupuncture for menopausal vasomotor symptoms: study ... If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms.

7. nccih.nih.gov nccih.nih.gov/health/acupuncture-effectiveness-and-safety

Acupuncture: Effectiveness and Safety - nccIH.nih.gov In a 2018 review, data from 12 studies (8,003 participants) showed acupuncture was more effective than no treatment for back or neck pain, and data from 10 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2095496425001104

Electroacupuncture for hot flashes in early menopause Our previous clinical studies involving over 150 perimenopausal participants also found that acupuncture was safe for treating menopause-related ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02098928

Comparison Between Hand-acupuncture and Electro ... Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. Intervention/Treatment, Behavioral : Hand-acupuncture.

10. acpjournals.org acpjournals.org/doi/10.7326/M15-1380

Acupuncture for Menopausal Hot Flashes: A Randomized ... Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.