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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weidong Lu, MB, MPH, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35238615 | Result | Yang E, Lu W, Giobbie-Hurder A, Shin IH, Chen WY, Block CC, Partridge A, Jeselsohn RM, Tolaney SM, Freedman RA, Ligibel JA. Auricular Acupuncture During Chemotherapy Infusion in Breast Cancer Patients: A Feasibility Study. J Integr Complement Med. 2022 May;28(5):427-435. doi: 10.1089/jicm.2021.0256. Epub 2022 Mar 2. |
| Label | URL |
|---|---|
| PubMed link | View source |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemotherapy Education (Cycle 2) |
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| Auricular Acupuncture (Cycle 3) |
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| Auricular Acupuncture (Cycle 4) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | 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 |
|
Participants were followed up to 12 weeks.
No SAE were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cycle 2 (Education Cycle) | During the second cycle of chemotherapy after study enrollment, 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. |
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This was a pilot feasibility study with a small sample size, so data pertaining to patient-reported outcomes should be considered preliminary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weidong Lu, MB, MPH, PhD | Dana-Farber Cancer Institute | 617-632-3322 | weidong_lu@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2017 | Apr 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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. | 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. | 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. | Participants were followed up to 12 weeks. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ESAS-R Total Score | Edmonton Symptom Assessment System-Revised (ESAS-R) is a simple, 9-item scale that has been validated for assessing self-reported severity of common symptoms in cancer populations, and was used to evaluate symptom burden in this study. There are 9 symptoms included in this questionnaire: pain, fatigue, drowsiness, nausea, loss of appetite, shortness of breath, depression, anxiety, and lack of well-being. Each symptom is scored from 0 to 10 on a 11-point numerical rating scale. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden. | Mean | Standard Deviation | units on a scale |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at pre-education on day 1 (T1), post-education on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 2 (Education) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| 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. | Posted | Number | participants | Participants were followed up to 12 weeks. |
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Cycle 3 (Acupuncture Cycles) | During the third cycle of chemotherapy after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Cycle 4 (Acupuncture Cycles) | During the fourth cycle of chemotherapy after study enrollment, the same participants received a 30-minute standardized auricular acupuncture treatment during chemotherapy infusion. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| T4 (day 5) vs. T1 (pre) |
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| T2 (post) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles) |
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| T3 (day 2) vs. T1 (pre): Cycle 2 (Education cycle) |
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| T3 (day 2) vs. T1 (pre): Cycle 3 &4 (Acupuncture cycles) |
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| T4 (day 5) vs. T1 (pre): cycle 2 (Education cycle) |
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| T4 (day 5) vs. T1 (pre): Cycle 3&4 (Acupuncture cycles) |
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