Auricular Point Acupressure for the Treatment of Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors

Status: Active

Description

This early phase I trial studies how well auricular point acupressure therapy works in treating aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure stimulates specific points on the ear to provide quick pain relief. Auricular point acupressure may help reduce the side effects of aromatase inhibitor treatment while avoiding additional side effects.

Eligibility Criteria

Inclusion Criteria

  • Pre- and postmenopausal women with a history of breast cancer (BC)
  • Currently receiving aromatase inhibitors (AIs) per chart documentation
  • Able to read and write English
  • Have joint pain attributable to AI

Exclusion Criteria

  • Metastatic BC
  • Completed cytotoxic chemotherapy or radiation therapy less than 4 weeks prior to enrollment

Locations & Contacts

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Chao Hsing Yeh
Phone: 410-502-0184

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To develop a smartphone application (app) so that breast cancer survivors (BCS) can learn auricular point acupressure (APA) to self-manage aromatase inhibitor musculoskeletal symptoms (AIMSS).

II. To examine clinical outcomes of the APA on AIMSS between three groups of BCS who will receive: (1) APA app with in-person training; (2) APA app only for self-learning; and (3) education to control time and attention.

III. To explore the central and peripheral modulatory analgesic effects of APA on AIMSS among three groups of BCS with AIMSS.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive in-person training on APA once weekly and use APA smartphone app for 4 weeks.

ARM II: Participants use APA smartphone app for 4 weeks.

ARM III: Participants receive educational intervention to control time and attention for 4 weeks.

After completion of study, participants are followed up monthly for 3 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Chao Hsing Yeh

Trial IDs

Primary ID J17176
Secondary IDs NCI-2019-06178, IRB00158622, CRMS-68017
Clinicaltrials.gov ID NCT03697200