Trial Outcomes & Findings for Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial (NCT NCT03783546)
NCT ID: NCT03783546
Last Updated: 2026-03-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
10 weeks
Results posted on
2026-03-09
Participant Flow
84 patients consented, and 78 patients were randomized.
Enrollment: Accrual began in January-February 2019. DFCI site suspended study accrual for several months during the COVID-19 pandemic and resumed when approved by local authorities. DFCI completed accrual in June 2021, meeting its accrual goal. Due to the pandemic, 84 patients who consented to participate but 6 were not able to be randomized to the study therapy.
Participant milestones
| Measure |
Immediate Acupuncture
* received 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 crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
Delayed Acupuncture
* received standard usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Delayed Acupuncture
n=39 Participants
* received standard, usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
Total
n=78 Participants
Total of all reporting groups
|
Immediate Acupuncture
n=39 Participants
* received 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 crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
3 Participants
n=68 Participants
|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 7.7 • n=69 Participants
|
49 Years
STANDARD_DEVIATION 9.45 • n=137 Participants
|
50.3 Years
STANDARD_DEVIATION 11.2 • n=68 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=69 Participants
|
78 Participants
n=137 Participants
|
39 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=69 Participants
|
63 Participants
n=137 Participants
|
33 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
2 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=69 Participants
|
78 participants
n=137 Participants
|
39 participants
n=68 Participants
|
|
Hot Flash Score
|
11.0 HFS units on a scale
STANDARD_DEVIATION 7.2 • n=69 Participants
|
10.25 HFS units on a scale
STANDARD_DEVIATION 7.0 • n=137 Participants
|
9.5 HFS units on a scale
STANDARD_DEVIATION 6.8 • n=68 Participants
|
|
ESS of FACT-ES
|
51.6 units on a scale
STANDARD_DEVIATION 8.5 • n=69 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 8.65 • n=137 Participants
|
50.0 units on a scale
STANDARD_DEVIATION 8.8 • n=68 Participants
|
|
FACT-B Total Score
|
103.6 FACT-B total score
STANDARD_DEVIATION 16.3 • n=69 Participants
|
103.05 FACT-B total score
STANDARD_DEVIATION 17.1 • n=137 Participants
|
102.5 FACT-B total score
STANDARD_DEVIATION 17.9 • n=68 Participants
|
PRIMARY outcome
Timeframe: 10 weeksDaily 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.
Outcome measures
| Measure |
Immediate Acupuncture
n=29 Participants
* received a standardized acupuncture protocol for a 10-week period
* 20 sessions: twice a week for 10 weeks
* After the completion of the 10-week main study period, participants crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
Delayed Acupuncture
n=30 Participants
* received standard, usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
|---|---|---|
|
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
|
-5.3 HFS score on a scale
Standard Deviation 3.9
|
-0.5 HFS score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 10 weeksChanges 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.
Outcome measures
| Measure |
Immediate Acupuncture
n=29 Participants
* received a standardized acupuncture protocol for a 10-week period
* 20 sessions: twice a week for 10 weeks
* After the completion of the 10-week main study period, participants crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
Delayed Acupuncture
n=30 Participants
* received standard, usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
|---|---|---|
|
Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer
|
6.6 FACT-B total score
Standard Deviation 11.3
|
-1.9 FACT-B total score
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Immediate Acupuncture
n=29 Participants
* received a standardized acupuncture protocol for a 10-week period
* 20 sessions: twice a week for 10 weeks
* After the completion of the 10-week main study period, participants crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
Delayed Acupuncture
n=30 Participants
* received standard, usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
|---|---|---|
|
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
|
5.3 ESS score on FACT-ES
Standard Deviation 7.0
|
-0.5 ESS score on FACT-ES
Standard Deviation 6.6
|
Adverse Events
Immediate Acupuncture (Treatment Weeks 1-10)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Delayed Acupuncture (Usual Care Weeks 1-10)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Acupuncture (Usual Care Weeks 11-20)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Acupuncture (Intervention Weeks 11-20)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Acupuncture (Treatment Weeks 1-10)
n=39 participants at risk
* received 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 crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Acupuncture: 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
|
Delayed Acupuncture (Usual Care Weeks 1-10)
n=39 participants at risk
* received standard usual care without acupuncture for 10 weeks
* Participants crossed over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Usual Care: the current standard of care with non-hormonal pharmacotherapy of western medicine
|
Immediate Acupuncture (Usual Care Weeks 11-20)
n=39 participants at risk
-After the completion of the 10 weeks main study period, participants crossed over to the usual care as a follow-up without acupuncture for additional 10 weeks.
|
Delayed Acupuncture (Intervention Weeks 11-20)
n=39 participants at risk
-Participants crossed over to receive the same acupuncture protocol for 10 weeks
--10 sessions: once a week for 10 weeks before exiting the study
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.6%
1/39 • Number of events 1 • 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.
|
0.00%
0/39 • 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.
|
0.00%
0/39 • 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.
|
0.00%
0/39 • 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.
|
|
Cardiac disorders
heart palpitations
|
2.6%
1/39 • Number of events 1 • 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.
|
0.00%
0/39 • 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.
|
0.00%
0/39 • 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.
|
0.00%
0/39 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place