Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
- Conditions
- Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerRecurrent Breast CancerStage I Breast CancerStage II Breast CancerStage IIIC Breast Cancer
- Interventions
- Procedure: acupuncture therapyProcedure: sham intervention
- Registration Number
- NCT01013337
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (Acupuncture) acupuncture therapy Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments). Arm II (Placebo) sham intervention 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.
- Primary Outcome Measures
Name Time Method Pain as measured by Brief Pain Inventory (BPI) pain severity score
- Secondary Outcome Measures
Name Time Method 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 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 BPI pain-related interference Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
Trial Locations
- Locations (1)
Abramson Cancer Center of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States