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

Study Overview
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Brief Summary
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This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-related Adverse Events (Safety) | Incidence of Treatment-related Adverse Events will be assessed by CTCAE v4.0 during chemotherapy infusion | From starting chemotherapy infusion up to 5 days of post-infusion | 
| The numbers of study patients being recruited and retained (Feasibility) | The numbers of study patients being recruited and retained during the study period will be documented as planned | from the activation of the study to the completion of the recruitment, 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Edmonton Symptom Assessment System (ESAS) score relative to Baseline | Edmonton Symptom Assessment System (ESAS) Total Score will be collected at 4 time points during each cycle | from baseline to Day 5 after chemotherapy infusion | 
| Changes in State-Trait Anxiety Inventory (STAI) score relative to Baseline | State-Trait Anxiety Inventory (STAI) score will be collected at 4 time points during each cycle. | from baseline to Day 5 after chemotherapy infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Breast Cancer