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

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Device: Acupuncture

Registration Number: NCT03170648

Lead Sponsor: Dana-Farber Cancer Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.