Abstract S3-03: Randomized trial of exercise vs. usual care on aromatase inhibitor-associated arthralgias in women with breast cancer: The hormones and physical exercise (HOPE) study
Authors: Irwin ML , Cartmel B , Gross C , Ercolano E , Fiellin M , Capozza S , Rothbard M , Zhou Y , Harrigan M , Sanft T , Schmitz K , Neogi T , Hershman D , Ligibel J 
Published: August 2014

PURPOSE: Arthralgias occur in up to 50% of women with breast cancer treated with adjuvant aromatase inhibitors (AIs), and are one of the most common reasons for poor adherence to therapy. We examined whether a year-long exercise program improves arthralgias in breast cancer survivors taking AIs.

METHODS: Postmenopausal women diagnosed with hormone receptor-positive breast cancer were identified via the Connecticut Tumor Registry. Women who were taking an AI for at least 6-months and reported ≥ 3 out of 10 on the worst joint pain item of the Brief Pain Inventory-Short Form (BPI) were eligible and randomized to either exercise (150 min/wk of moderate-intensity aerobic exercise and twice-weekly supervised resistance exercise sessions) or usual care. The BPI questionnaire was completed at baseline, 6- and 12-months. VO2 max testing and Dual Energy X-ray Absorptiometry (DEXA) scans were also collected at baseline, 6- and 12-months. The primary outcome was change in BPI worst joint pain score between 0 and 12 months. We performed intent-to-treat statistical analyses including analysis of covariance, where each participant's change in outcome was modeled as a function of randomization group

RESULTS: Out of 728 women screened that were taking an AI, we randomized 121 women, with 61 women randomized to exercise and 60 women randomized to usual care. Baseline characteristics were comparable between the two groups. Over 12 months, women randomized to exercise attended, on average, 80% ± 14% of the twice-weekly supervised resistance training exercise sessions and participated in an average 146 ± 75 min/wk of at least moderate-intensity aerobic exercise. Worst joint pain scores decreased by 20% at 12 months among women randomized to exercise vs. a 3% decrease among women randomized to usual care (p = .017). Joint pain severity also decreased significantly in exercise vs. usual care groups (p = 0.025), as well as joint pain-related interference (p = 0.005). The exercise intervention also favorably impacted body weight (p = 0.0057) and cardiorespiratory fitness (p = 0.024).

Baseline to 12 month changes in BPI joint pain scores (mean (SD)) Baseline Values  Change from baseline to 12 months  BPI ItemExercisersUsual Carep-valueExercisersUsual Carep-valueWorst Pain5.5 (1.9)5.9 (1.9)0.29-1.1 (2.5)-0.2 (1.6)0.017Pain Severity3.9 (1.6)4.3 (1.8)0.27-0.8 (2.1)0.0 (1.5)0.025Pain Interference2.8 (2.1)2.9 (2.3)0.81-0.8 (2.0)0.2 (1.9)0.005Body weight (kg)80.9 (16.8)74.6 (14.5)0.11-3.5 (6.0)0.1 (3.7)0.0057VO2max (ml/kg/min)23.5 (4.8)23.1 (4.3)0.751.9 (1.9)0.4 (2.7)0.024

CONCLUSION: We found that participating in an exercise intervention led to clinically meaningful improvements in AI-induced arthralgias in breast cancer survivors experiencing moderate joint pain. The intervention also induced favorable changes in body weight and cardiorespiratory fitness, factors that may be linked to incidence and severity of AI-induced arthralgias. Further work is needed to determine whether exercise leads to increased AI adherence and possibly better outcomes in women with breast cancer.

Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S3-03.