S1200: Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Pts W/Early-Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01535066|
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : December 11, 2019
RATIONALE: Acupuncture may help relieve joint pain.
PURPOSE: This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or waitlist in treating patients with joint pain related to aromatase inhibitors in patients with early-stage breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Pain||Procedure: acupuncture therapy Procedure: sham acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Factorial Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer|
|Actual Study Start Date :||March 27, 2012|
|Actual Primary Completion Date :||June 15, 2017|
|Actual Study Completion Date :||July 2018|
Experimental: Arm I
Patients receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Procedure: acupuncture therapy
Sham Comparator: Arm II
Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Procedure: sham acupuncture
Receive sham acupuncture
No Intervention: Arm III
Patients are assigned to a waiting list for 12 weeks with standard follow-up care.
- Decrease of joint pain associated with the use of AIs as measured by BPI-SF [ Time Frame: 6 weeks ]
- Benefit of acupuncture maintenance as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 6, 12, 16, 20, and 24 weeks ]
- Durability of response as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 52 weeks. ]
- Long-term effects of acupuncture as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 52 weeks ]
- Analgesic and opioid use [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ]
- AI adherence [ Time Frame: 12, 24, and 52 weeks ]
- Safety and tolerability of acupuncture [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ]
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): NCT01535066
|Principal Investigator:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|