Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain

April 7, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

Acupuncture and Aromatase Inhibitor Related Arthralgia

RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors.

PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the overall effect of acupuncture for reducing arthralgia among breast cancer survivors (BCS) receiving AIs.

II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS receiving AIs.

III. To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of BPI pain severity score at the end of intervention.

SECONDARY OBJECTIVES:

I. To explore the effects of acupuncture on other common symptoms including fatigue, insomnia, and psychological distress among BCS who experience joint pain.

II. To determine the correlation among pain and fatigue, insomnia, and psychological distress using previously validated instruments.

III. To explore the effects of acupuncture on quality of life among BCS who experience joint pain.

IV. To explore the effect of acupuncture on objective measure of sleep and activity.

V. To identify potential genetic determinants to response to acupuncture.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).

ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.

ARM III (Control): Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

After completion of study treatment, patients are followed at 4 weeks.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion

  • History of stage I, II, or III breast cancer
  • Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
  • Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction
  • Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL
  • Can understand written English
  • Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
  • Having had at least 15 days with pain in the preceding 30 days
  • Having had joint pain for at least 3 months
  • Joint pain attributed to the use of aromatase inhibitors
  • Willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control

Exclusion

  • Women with metastatic (stage IV) breast cancer
  • Women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
  • History of bleeding disorder
  • Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
  • Having severe pain or non-inflammatory arthralgia prior to AI initiation per patient's history
  • Surgery or joint injection involving the treatment joint within the last 3 months
  • Have previously participated in the acupuncture trial for hot flashes in the last year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Acupuncture)
Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
Procedure: acupuncture therapy
Other Names:
  • acupuncture
Sham Comparator: Arm II (Placebo)
Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.
Procedure: sham intervention
Placebo acupuncture
No Intervention: Arm III (Control)
Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain as measured by Brief Pain Inventory (BPI) pain severity score

Secondary Outcome Measures

Outcome Measure
BPI pain-related interference
Arthritis/disability specific outcomes as assessed by WOMAC index for lower extremities, quick D.A.S.H. for upper extremities, and the Physical Performance Test, 9-item
Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
Other coexisting symptoms such as fatigue, psychological distress, and insomnia as assessed by the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, and City of Hope Quality of Life Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Jun Mao, Abramson Cancer Center of The University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 21, 2016

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 07109
  • NCI-2009-01358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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