Trial Outcomes & Findings for Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study (NCT NCT03170648)

Last Updated: 2025-04-30

Results Overview

Feasibility was measured by: Enrollment of at least 20 patients (80% of the target sample size) within 3 months. Completion of at least 75% of scheduled auricular acupuncture sessions. Completion of at least 75% of ESAS assessments. Methods: Data were collected from patient enrollment logs, session attendance records, and ESAS assessment completion records.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Enrollment data over 3 months; Acupuncture attendance was recorded during Chemotherapy Cycles 2,3,4 ESAS were conducted at four time points for each cycle ESAS Assessments: Completion will were recorded up to 5 days post-infusion for Cycle 2-4

Results posted on

2025-04-30

Participant Flow

The study enrolled 26 patients. Each patient is as its own control with education (cycle 2 of treatment) vs. the acupuncture (cycle 3 and 4 of treatment).

Participant milestones

Participant milestones
Measure	All Participants During the first cycle of chemotherapy after study enrollment, participants (cycle 2 of treatment) were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy after study enrollment (cycle 3 and 4 of treatment), the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Chemotherapy Education (Cycle 2) STARTED	26
Chemotherapy Education (Cycle 2) COMPLETED	25
Chemotherapy Education (Cycle 2) NOT COMPLETED	1
Auricular Acupuncture (Cycle 3) STARTED	25
Auricular Acupuncture (Cycle 3) COMPLETED	24
Auricular Acupuncture (Cycle 3) NOT COMPLETED	1
Auricular Acupuncture (Cycle 4) STARTED	24
Auricular Acupuncture (Cycle 4) COMPLETED	24
Auricular Acupuncture (Cycle 4) NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants During the first cycle of chemotherapy after study enrollment, participants (cycle 2 of treatment) were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy after study enrollment (cycle 3 and 4 of treatment), the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Chemotherapy Education (Cycle 2) schedule conflict	1
Auricular Acupuncture (Cycle 3) Adverse Event	1

Baseline Characteristics

Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=26 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy after study enrollment (cycle 3 and 4 of treatment), the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Age, Continuous	46.5 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
ESAS-R Total Score	7.4 units on a scale STANDARD_DEVIATION 13.1 • n=5 Participants

PRIMARY outcome

Timeframe: Enrollment data over 3 months; Acupuncture attendance was recorded during Chemotherapy Cycles 2,3,4 ESAS were conducted at four time points for each cycle ESAS Assessments: Completion will were recorded up to 5 days post-infusion for Cycle 2-4

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy (cycle 3 and 4 of treatment) after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Feasibility of Patient Enrollment and Intervention Adherence Percentage of target sample size	100 percentage of participants
Feasibility of Patient Enrollment and Intervention Adherence Percentage of participants completed auricular acupuncture sessions	92.3 percentage of participants
Feasibility of Patient Enrollment and Intervention Adherence Percentage of participants complete ESAS assessments	84.6 percentage of participants

SECONDARY outcome

Timeframe: Assessed at pre-education on day 1 (T1), post-education on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 2 (Education)

The Edmonton Symptom Assessment System-Revised Version (ESAS-R) is a 9-item scale that assesses the current severity of common symptoms. The ESAS-R has been validated in cancer populations. Each symptom is scored from 0 to 10 on an 11-point numerical rating scale, with total scores ranging from 0 to 90. Higher scores indicate a greater symptom burden.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy (cycle 3 and 4 of treatment) after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2) T2 vs. T1	-1.1 score on a scale Standard Deviation 4.6
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2) T3 vs. T1	1.4 score on a scale Standard Deviation 15.2
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2) T4 vs. T1	7.4 score on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: Assessed at pre-acupuncture on day 1 (T1), post-acupuncture on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 3 and cycle 4 (Acupuncture Cycles). Participants were followed up to 12 weeks.

Scores of cycle 3 and cycle 4 are averaged. The Edmonton Symptom Assessment System-Revised Version (ESAS-R) is a 9-item scale that assesses the current severity of common symptoms. The ESAS-R has been validated in cancer populations. Each symptom is scored from 0 to 10 on an 11-point numerical rating scale, with total scores ranging from 0 to 90. Higher scores indicate a greater symptom burden.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy (cycle 3 and 4 of treatment) after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) T1	17.3 score on a scale Standard Deviation 12.3
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) T2 (post) vs. T1 (pre)	-3.0 score on a scale Standard Deviation 5.6
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) T3 (day 2) vs. T1 (pre)	-2.3 score on a scale Standard Deviation 10.2
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) T4 (day 5) vs. T1 (pre)	-0.5 score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: STAI were collected at four time points for each of the three cycles: 1) On the day of chemotherapy infusion or day 1, pre-education/acupuncture (T1); 2) Day 1, immediate post-education/acupuncture (T2); 3) Day 2 (T3); 4) Day 5 follow-up (T4)

Population: Patient-reported outcomes (ESAS-R, STAI-S, and MAT scores) during cycles 3 and 4 (acupuncture cycles) at each time point were averaged and compared with outcomes from cycle 2 (education cycle) using paired t-tests. The change from T1 to T2 is reported below.

State-Trait Anxiety Inventory-State (STAI-S) is a validated and commonly used measure for evaluating a patient's current state of anxiety. It has been widely used in cancer populations. It consists of 20 items, with each item scored from 1 to 4, and the total score ranges from 20 to 80. Higher scores indicate a greater level of anxiety.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy (cycle 3 and 4 of treatment) after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T1 (pre) Cycle 2 (Education cycle)	37.9 score on a scale Standard Deviation 11.0
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T1 (pre): Cycle 3&4 (Acupuncture cycles)	35.6 score on a scale Standard Deviation 11.8
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T2 (post) vs. T1 (pre): cycle 2 (Education cycle)	-1.5 score on a scale Standard Deviation 4.3
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T2 (post) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles)	-4.9 score on a scale Standard Deviation 5.0
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T3 (day 2) vs. T1 (pre): Cycle 2 (Education cycle)	0.0 score on a scale Standard Deviation 9.3
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T3 (day 2) vs. T1 (pre): Cycle 3 &4 (Acupuncture cycles)	-2.6 score on a scale Standard Deviation 5.7
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T4 (day 5) vs. T1 (pre): cycle 2 (Education cycle)	5.5 score on a scale Standard Deviation 9.8
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) T4 (day 5) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles)	0.4 score on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Participants were followed up to 12 weeks.

The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 were used to collect safety data related to adverse events, including skin bruising, hematoma, pre- syncope, syncope, and nausea.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants During the first cycle of chemotherapy after study enrollment (cycle 2 of treatment), participants were provided with an educational booklet developed by the National Cancer Institute. This booklet included information on chemotherapy, its side effects, and strategies for self-care. During the second and third cycles of chemotherapy (cycle 3 and 4 of treatment) after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion.
Number of Participants Experienced Acupuncture-related Adverse Effects	0 participants

Adverse Events

Cycle 2 (Education Cycle)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cycle 3 (Acupuncture Cycles)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cycle 4 (Acupuncture Cycles)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Weidong Lu, MB, MPH, PhD

Dana-Farber Cancer Institute

Phone: 617-632-3322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place