NCT03783546

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

Completed NA Results posted Last updated 9 March 2026

What this trial tests

NA trial testing Acupuncture in Breast Cancer in 84 participants. Completed in 31 January 2022.

Timeline

15 January 2019

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	84
Start date	15 January 2019
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Acupuncture — full drug profile →
• Usual Care

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Immediate Acupuncture	-5.3	± 3.9
Delayed Acupuncture	-0.5	± 6.5

Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer Secondary · 10 weeks

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.

Group	Value	95% CI
Immediate Acupuncture	6.6	± 11.3
Delayed Acupuncture	-1.9	± 8.4

Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) Secondary · 10 weeks

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.

Group	Value	95% CI
Immediate Acupuncture	5.3	± 7.0
Delayed Acupuncture	-0.5	± 6.6

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Immediate Acupuncture (Treatment Weeks 1-10)

Serious: 0/39 (0%)

Deaths: 0/39

Delayed Acupuncture (Usual Care Weeks 1-10)

Serious: 0/39 (0%)

Deaths: 0/39

Immediate Acupuncture (Usual Care Weeks 11-20)

Serious: 0/39 (0%)

Deaths: 0/39

Delayed Acupuncture (Intervention Weeks 11-20)

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (2 terms — click to expand)

Reaction	System	Immediate Acupuncture (Tre…	Delayed Acupuncture (Usual…	Immediate Acupuncture (Usu…	Delayed Acupuncture (Inter…
Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
heart palpitations	Cardiac disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03783546 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.
   Baedorf Kassis S, Lu W, White SA, Shin IH, et al · · 2022 · PMID 35715806 · DOI 10.1186/s12906-022-03648-4