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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170648
• Other study ID #: 17-065
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   PubMed link