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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2016-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acupuncture in Reducing Muscle and Bone Symptoms in Women Receiving Letrozole, Exemestane, or Anastrozole for Stage 0, Stage I, Stage II, or Stage III Breast Cancer

NCT00641303

Anxiety Disorder Breast Cancer Depression +4 more

COMPLETED NA

Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer

NCT06534125

Anatomic Stage I Breast Cancer AJCC V8 Anatomic Stage II Breast Cancer AJCC V8 Anatomic Stage III Breast Cancer AJCC V8 +2 more

RECRUITING NA

Treatment for Joint Pains Due to Aromatase Inhibitor Therapy in Breast Cancer

NCT01612728

Breast Cancer Arthralgia Joint Pain

WITHDRAWN PHASE2

Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

NCT02831582

Arthralgia Breast Neoplasms

COMPLETED NA

A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy

NCT05921617

Musculoskeletal Health

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Recurrent Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (Acupuncture)

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

Group Type EXPERIMENTAL

acupuncture therapy

Intervention Type PROCEDURE

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.

Group Type SHAM_COMPARATOR

sham intervention

Intervention Type PROCEDURE

Placebo acupuncture

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture therapy

Intervention Type PROCEDURE

sham intervention

Placebo acupuncture

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

acupuncture

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No