Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
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|ClinicalTrials.gov Identifier: NCT01013337|
Recruitment Status : Active, not recruiting
First Posted : November 13, 2009
Last Update Posted : August 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture and Aromatase Inhibitor Related Arthralgia|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2012|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|