Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial
Official title:
Improving Health of Women on Aromatase Inhibitors
This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.
PRIMARY OBJECTIVES: I. To recruit an ethnically, racially and culturally diverse sample of postmenopausal women diagnosed with estrogen receptor positive breast cancer who are currently taking aromatase inhibitor (AI), establish eligibility, and randomly allocate 20 participants to a two-arm parallel intervention trial. II. Conduct baseline measurements of: body composition and bone mineral density, reported muscle and joint pain; inflammatory, cardiovascular and bone health markers contained in blood serum; and, cardiovascular function. III. Conduct a three month anti-inflammatory dietary intervention in one arm, and bone strengthening exercise intervention in the other study arm. IV. At completion of these 3-month interventions, evaluate changes since baseline of body composition, bone density, reported muscle and joint pain, and inflammatory and cardiovascular measurements within each intervention arm, and preliminarily contrast changes between intervention arms. V. Utilize results from both intervention arms to design a larger 2x2 randomized factorial trial designed to assess effects of anti-inflammatory diet, effects of bone promoting exercise, and combined diet and exercise intervention effects on joint and muscle pain, inflammatory markers, bone mineral density, and cardiovascular measures. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive a controlled anti-inflammatory diet over 12 weeks. ARM II: Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks. After completion of study, patients are followed up at 1 week. ;
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