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NCT03697200 · ClinicalTrials.gov registry record · NA

Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings

A NA study of Aromatase Inhibitor and Musculoskeletal Symptoms, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
102
Enrollment target
1
Study location

NCT03697200: Completed NA study of Aromatase Inhibitor and Musculoskeletal Symptoms, sponsored by Johns Hopkins University.

NCT03697200 is a NA study of Aromatase Inhibitor and Musculoskeletal Symptoms that has completed, run by Johns Hopkins University. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03697200, a NA study of Aromatase Inhibitor and Musculoskeletal Symptoms, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
102 participants
Enrollment target
1
Study location

Study Summary

Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care. The investigators propose to test auricular point acupressure- -an innovative, non-invasive, nonpharmacologic, and low-cost intervention- -to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these. This study wil

Primary Outcome

The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

Interventions

  • OTHER Education control
  • OTHER APA
  • OTHER Sham APA control

Study Locations (1)

Maryland

  • Johns Hopkins School of Nursing - Baltimore

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2018-11-11
Est. Completion 2020-12-30
Phase NA
Johns Hopkins University

1,448 total trials

What the finished NCT03697200 record still lists

NCT03697200 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 3 conditions, with Aromatase Inhibitor appearing as the primary indexed condition, and to 3 interventions - of which Education control is the first listed.

NCT03697200 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03697200 about?

NCT03697200 is a clinical study titled "Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings". Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and s...

What is the current status of trial NCT03697200?

This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2018-11-11. Estimated completion is 2020-12-30.

What conditions does trial NCT03697200 study?

This clinical trial studies the following conditions: Aromatase Inhibitor, Musculoskeletal Symptoms, Postmenopausal Breast Cancer Survivors.

What interventions are being tested in trial NCT03697200?

The interventions under investigation include: Education control (OTHER), APA (OTHER), Sham APA control (OTHER).

Who is sponsoring clinical trial NCT03697200?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03697200 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03697200's enrollment target sits among peer trials

102 837th of 2000 higher than 1,161 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03697200, the US trial registry maintained by the National Library of Medicine. NCT03697200 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.