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

NCT03170648 | Completed Results DMC FDA Device

• 1 other identifier: 17-065
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Acupuncture; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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)

• 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.

• 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)

• Number of Participants Experienced Acupuncture-related Adverse Effects

  Participants were followed up to 12 weeks.

Study Arms (1)

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

Device: Acupuncture

Interventions

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

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related 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 May;28(5):427-435. doi: 10.1089/jicm.2021.0256. Epub 2022 Mar 2.

  PMID: 35238615 RESULT

Related Links

• PubMed link

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

This was a pilot feasibility study with a small sample size, so data pertaining to patient-reported outcomes should be considered preliminary.

Results Point of Contact

• Title: Weidong Lu, MB, MPH, PhD
• Organization: Dana-Farber Cancer Institute

weidong_lu@dfci.harvard.edu

617-632-3322

Study Officials

• Weidong Lu, MB, MPH, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: June 19, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 30, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)