Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
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.
|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||Procedure: acupuncture therapy Procedure: sham intervention||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acupuncture and Aromatase Inhibitor Related Arthralgia|
- Pain as measured by Brief Pain Inventory (BPI) pain severity score
- 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
|Study Start Date:||May 2009|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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 Name: 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
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.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013337
|United States, Pennsylvania|
|Abramson Cancer Center of The University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jun Mao||Abramson Cancer Center of the University of Pennsylvania|