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

Breast Cancer Clinical Trial

Official title:

Acupuncture and Aromatase Inhibitor Related Arthralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013337
• Other study ID #: UPCC 07109
• Secondary ID: NCI-2009-01358
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: April 21, 2016

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 21, 2016
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• acupuncture therapy

• sham intervention
Placebo acupuncture

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by Brief Pain Inventory (BPI) pain severity score
Secondary	BPI pain-related interference
Secondary	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
Secondary	Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
Secondary	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