Abstract OT3-02-04: A randomized controlled trial comparing acupuncture versus usual care for the treatment of aromatase inhibitor-induced arthralgia (AIIA) in women with early-stage breast cancer
Authors: Frank HS , Bendinger GM , Ensor JE , Neufeld N , Nixon D , Randolph K , McGuire E , Rados K , McNight JE , Pabbathi H , Panicker R , Johnson AT , Lammersfeld C , Alvarez R 
Published: March 2017

Abstract
BACKGROUND: The increase in breast cancer (BC) survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing BC recurrences. However, BC patients receiving AIs have a higher incidence of osteoporosis, bone fractures, and musculoskeletal symptoms, particularly joint pain and stiffness. The incidence of AIIA in the ATAC trial was 27.8% in patients taking anastrozole versus (vs) 21% in patients taking tamoxifen (Baum M, Lancet 2002). The arthralgia associated with AIs can be so debilitating that it contributes to a significant percentage of non-compliance and discontinuation of systemic treatment. Patients with cancer often show interest in complementary and integrative modalities for symptom management (Vickers AJ, Lancet 2001), of which Acupuncture (Ac) is one of the most utilized therapies.
ELIGIBILITY: Subjects must be female ≥18 years, have undergone mastectomy or breast-sparing surgery, and must have recovered from all pain-related effects of the surgery and radiotherapy with a minimum washout period of 30 days prior to registration. Patients should have ER and PR positive BC and be actively taking a 3rd-generation AI (Anastrozole, Letrozole, or Exemestane) for at least the 30 days prior to registration and plan to continue for at least one year after registration. ECOG PS &lt;2 and platelets counts &gt; 50,000/uL. Patients must not have received topical analgesic with exception of oral NSAIDS drugs ≤14 days to registration.
TRIAL DESIGN: This is a 12-week, two arm randomized (1:1) trial evaluating the benefit of Ac in BC patients experiencing AIIA.
AIMS: The aim of this study is to investigate the effectiveness of an integrative approach using Ac vs usual care (UC) treatment consisting of NSAIDs for the management of the AIIA.Primary endpoint is to compare the difference of Brief Pain Inventory-Short Form (BPI-SF) score at baseline vs week 8 between Ac and UC groups. Secondary endpoints are a) to compare the difference of BPI-SF score at baseline vs week 12 between Ac and UC groups, b) to compare the difference in AI adherence between Ac and UC groups and c) to compare the difference in patient initiated AI discontinuation between Ac and UC groups.
STATS/TARGET ACCRUAL: This is a randomized controlled phase II study with the goal to compare reduction in BPI-SF score for patients treated with Ac vs UC alone. Patients are randomized 1:1 between the two arms. Prior work has indicated a 2-point BPI-SF score reduction as clinically meaningful. A sample size of 56 patients yields a study with 90% power and a one-sided significance level of 0.025 to determine a difference in pain reduction ≥2. These calculations are based on the assumptions of normal distribution of the improvement in BPI-SF score and a standard deviation that is conservatively calculated to be 2.3. An additional 6 patients will be accrued to account for attrition.
Citation Format: Frank HS, Bendinger GM, Ensor Jr. JE, Neufeld N, Nixon D, Randolph K, McGuire E, Rados K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Lammersfeld C, Alvarez R. A randomized controlled trial comparing acupuncture versus usual care for the treatment of aromatase inhibitor-induced arthralgia (AIIA) in women with early-stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-02-04.