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: 2025-05-04
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
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
10 weeks
Results posted on
2025-05-04
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 |
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
|
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
|
|---|---|---|---|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
47.7 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
49 Years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Hot Flash Score
|
9.5 HFS units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
11.0 HFS units on a scale
STANDARD_DEVIATION 7.2 • n=7 Participants
|
10.25 HFS units on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
ESS of FACT-ES
|
50.0 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
51.6 units on a scale
STANDARD_DEVIATION 8.5 • n=7 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
FACT-B Total Score
|
102.5 FACT-B total score
STANDARD_DEVIATION 17.9 • n=5 Participants
|
103.6 FACT-B total score
STANDARD_DEVIATION 16.3 • n=7 Participants
|
103.05 FACT-B total score
STANDARD_DEVIATION 17.1 • n=5 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