Breast Cancer
Conditions
Keywords
Acupuncture, Breast Cancer
Brief summary
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.
Detailed description
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.
Interventions
DEVICEAcupuncture
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
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of histologically or cytologically proven Stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Signed informed consent
Exclusion criteria
* Receiving weekly chemotherapy * Unstable cardiac disease or myocardial infarction within 6 months prior to study entry * Uncontrolled seizure disorder * Pregnancy or potential pregnancy * Active clinically significant uncontrolled infection * Prior use of acupuncture within 3 months prior to the study entry * Uncontrolled major psychiatric disorders, such as major depression or psychosis * Metastatic breast or other cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Patient Enrollment and Intervention Adherence | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2) | 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. |
| Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) | 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. |
| Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) | 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) | 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. |
| Number of Participants Experienced Acupuncture-related Adverse Effects | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Auricular Acupuncture (Cycle 3) | Adverse Event | 1 |
| Chemotherapy Education (Cycle 2) | schedule conflict | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 9.2 |
| ESAS-R Total Score | 7.4 units on a scale STANDARD_DEVIATION 13.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Feasibility of Patient Enrollment and Intervention Adherence | Percentage of target sample size | 100 percentage of participants |
| All Participants | Feasibility of Patient Enrollment and Intervention Adherence | Percentage of participants completed auricular acupuncture sessions | 92.3 percentage of participants |
| All Participants | Feasibility of Patient Enrollment and Intervention Adherence | Percentage of participants complete ESAS assessments | 84.6 percentage of participants |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
p-value: 0.02t-test, 2 sided
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants Experienced Acupuncture-related Adverse Effects | 0 participants |