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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2023-12-31

Brief Summary

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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No