An interventional study of Acupuncture in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.
Chemotherapy drugs used to treat cancer can cause many symptoms. Some of the most common symptoms of receiving chemotherapy are nausea, vomiting, and anxiety. These symptoms can affect the quality of life of cancer patients. Medications can help ease these, but many patients continue to experience symptoms despite these treatments.
Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea.
Ear acupuncture is a type of acupuncture that involves the stimulation of points on the external ear. A few studies have suggested that ear acupuncture may help to reduce symptoms of nausea and anxiety during chemotherapy.
This study is being done to evaluate the potential benefits of using ear acupuncture to reduce symptoms like nausea and anxiety for women receiving chemotherapy for breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive a 30-minute session of a standardized ear acupuncture treatment Acupuncture needles will be gently manipulated to increase stimulation For each ear acupuncture session, the patient will have ear acupuncture therapy administered to each ear
Device: Acupuncture
Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea
Feasibility of Patient Enrollment and Intervention Adherence
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.
Time frame: 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
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2)
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.
Time frame: Assessed at pre-education on day 1 (T1), post-education on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 2 (Education)
Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4)
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.
Time frame: 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.
Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4)
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.
Time frame: 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)
Number of Participants Experienced Acupuncture-related Adverse Effects
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.
Time frame: Participants were followed up to 12 weeks.
| Milestone | All Participants |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
| Withdrew: Schedule conflict | 1 |
| Milestone | All Participants |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | All Participants |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
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.
| percentage of participants | All Participants |
|---|---|
| Percentage of target sample size | 100 |
| Percentage of participants completed auricular acupuncture sessions | 92.3 |
| Percentage of participants complete ESAS assessments | 84.6 |
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.
| score on a scale | All Participants |
|---|---|
| T2 vs. T1 | -1.1 ± 4.6 |
| T3 vs. T1 | 1.4 ± 15.2 |
| T4 vs. T1 | 7.4 ± 13.1 |
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.
| score on a scale | All Participants |
|---|---|
| T1 | 17.3 ± 12.3 |
| T2 (post) vs. T1 (pre) | -3.0 ± 5.6 |
| T3 (day 2) vs. T1 (pre) | -2.3 ± 10.2 |
| T4 (day 5) vs. T1 (pre) | -0.5 ± 9.9 |
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.
| score on a scale | All Participants |
|---|---|
| T1 (pre) Cycle 2 (Education cycle) | 37.9 ± 11.0 |
| T1 (pre): Cycle 3&4 (Acupuncture cycles) | 35.6 ± 11.8 |
| T2 (post) vs. T1 (pre): cycle 2 (Education cycle) | -1.5 ± 4.3 |
| T2 (post) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles) | -4.9 ± 5.0 |
| T3 (day 2) vs. T1 (pre): Cycle 2 (Education cycle) | 0.0 ± 9.3 |
| T3 (day 2) vs. T1 (pre): Cycle 3 &4 (Acupuncture cycles) | -2.6 ± 5.7 |
| T4 (day 5) vs. T1 (pre): cycle 2 (Education cycle) | 5.5 ± 9.8 |
| T4 (day 5) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles) | 0.4 ± 6.2 |
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.
| participants | All Participants |
|---|---|
| Number of Participants Experienced Acupuncture-related Adverse Effects | 0 |
Collected over Participants were followed up to 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cycle 2 (Education Cycle) | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Cycle 3 (Acupuncture Cycles) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Cycle 4 (Acupuncture Cycles) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 46.5 ± 9.2 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 26 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 22 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 26 |
| ESAS-R Total Score(units on a scale) | All Participants |
|---|---|
| Mean | 7.4 ± 13.1 |
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Dana-Farber Cancer Institute