Breast CancerNCT03783546

Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

A study testing Acupuncture in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Acupuncture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2019to 31 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
Premenopausal or postmenopausal status;
Completed all primary chemotherapy and surgery;
Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry;
Age ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Signed informed consent

Who cannot join

Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;
Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
Uncontrolled seizure disorder or history of seizure;
Active clinically significant uncontrolled infection;
Use of acupuncture for hot flashes within 6 months prior to the study entry;
Uncontrolled major psychiatric disorders, such as major depression or psychosis;
Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Dana Farber Cancer Institute
Boston, Massachusetts, 02215

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About this study

Read the detailed description

Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot flashes are common side effects of breast cancer treatments and can affect mood and daily life. Medications can help ease hot flashes, but many patients continue to experience symptoms despite these treatments.

Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on the skin, with the goal of affecting body's natural healing system. Acupuncture has been tested in clinical trials in cancer patients and has been shown to be helpful in treating a number of side effects of cancer treatment, such as nausea and vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to lessen hot flashes, but more information is needed about the benefits of acupuncture in breast cancer patients.

This study is being done to test whether acupuncture can help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with mediations such as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).

Conditions: Breast Cancer
Being tested: Acupuncture, Usual Care
Keywords: Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureDevice
Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
Usual CareOther
the current standard of care with non-hormonal pharmacotherapy of western medicine

Study groups in NCT03783546
Study group	Role	What they receive
Immediate Acupuncture	Experimental	* 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. Receives: Device: Acupuncture
Delayed acupuncture	Active comparator	* 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 Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.
Measured: 10 weeks

Secondary outcomes (2)

Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer
Changes in scores were calculated as (Week-10 - baseline). Since a higher score on any FACT-B subscale indicates better quality of life, a positive change would suggest that the patient's score improved during that time interval.
Measured: 10 weeks
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
The ESS is one subscale of the FACT-ES that assesses hormonal symptoms of endocrine therapy. The score ranges from 0-76 with higher scores indicating greater freedom from symptoms. Changes in scores were calculated as (Week-10 - baseline). Since a higher score reflects increased freedom from hormonal symptoms, a positive change would suggest that the patient's symptoms improved during that time interval.
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201931 Jan 2022

First posted21 Dec 2018
Study start15 Jan 2019
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03783546
Sponsor's protocol ID: 18-371
Status last verified: Feb 2026
First submitted: 19 Dec 2018
Last updated: 9 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor- Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

Baedorf Kassis S, Lu W, White SA, Shin IH, Park SH, Jeong YJ, Yao C, Ligibel J, Bierer BE. Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial. BMC Complement Med Ther. 2022 Jun 17;22(1):161. doi: 10.1186/s12906-022-03648-4.
PubMed 35715806

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03783546
Acronym / sponsor ID: 18-371
Conditions: Breast Cancer
Keywords: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: The Comprehensive and Integrative Medicine Institute of South Korea
Study start: 15 Jan 2019 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 21 Dec 2018 (actual)
Results: Posted 18 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate Acupuncture	Experimental	Device: Acupuncture* 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.
Delayed acupuncture	Active comparator	Other: Usual Care* 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
Premenopausal or postmenopausal status;
Completed all primary chemotherapy and surgery;
Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry;

Key exclusion criteria (7 listed)

Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;
Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
Uncontrolled seizure disorder or history of seizure;
Active clinically significant uncontrolled infection;
Use of acupuncture for hot flashes within 6 months prior to the study entry;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureAcupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system	Device	Immediate Acupuncture
Usual Carethe current standard of care with non-hormonal pharmacotherapy of western medicine	Other	Delayed acupuncture

Primary outcome

Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
Time frame: 10 weeks
Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.

2 secondary outcomes

Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer
Time frame: 10 weeks
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
Time frame: 10 weeks

Results and safety

Results posted to the registry on 18 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Acupuncture	39	35
Delayed Acupuncture	39	36

Primary outcome: Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10

Time frame: 10 weeks. Mean (Standard Deviation). Unit: HFS score on a scale

Measure	Immediate Acupuncture n = 29	Delayed Acupuncture n = 30
Value	-5.3 (3.9)	-0.5 (6.5)

Immediate Acupuncture vs Delayed Acupuncture: p = 0.0003, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks: The adverse events were reported separately for each intervention phase to accurately capture the effects of the treatments. The study had two arms: Immediate Acupuncture Arm (Treatment Weeks 1-10) and (Usual Care Weeks 11-20) Adverse events were recorded during both the treatment and follow-up phases. Delayed Acupuncture Arm (Usual Care Weeks 1-10) and (Intervention Weeks 11-20) Adverse events were recorded during both the usual care and intervention phases.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Acupuncture (Treatment Weeks 1-10)	0 of 39 (0%)	2 of 39 (5.1%)	0 of 39
Delayed Acupuncture (Usual Care Weeks 1-10)	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Immediate Acupuncture (Usual Care Weeks 11-20)	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Delayed Acupuncture (Intervention Weeks 11-20)	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Limitations and caveats (from the sponsor): We randomized patients to immediate acupuncture vs. delayed acupuncture rather than using an active control condition. This raises the possibility that the placebo effect could have contributed to the impact of the immediate acupuncture intervention on hot flashes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35715806Baedorf Kassis S, Lu W, White SA, Shin IH, Park SH, Jeong YJ, Yao C, Ligibel J, Bierer BE. Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial. BMC Complement Med Ther. 2022 Jun 17;22(1):161. doi: 10.1186/s12906-022-03648-4.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weidong Lu, PhD, MPH principal investigator

Dana-Farber Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10 (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03783546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.