NCT01013337

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

Acupuncture and Aromatase Inhibitor Related Arthralgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	acupuncture therapy
PROCEDURE	sham intervention	Placebo acupuncture

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-10-01
• Completion: 2016-04-21
• First posted: 2009-11-13
• Last updated: 2020-04-08

Locations

1 site across 1 country: United States