Abstract
BACKGROUND: Older women with breast cancer are more likely than younger women to experience dose-limiting toxicities with chemotherapy. This leads to dose reduction, treatment discontinuation, and inferior treatment outcomes. Older women are also at higher risk of long-term detrimental impacts of treatment on quality of life and physical function. AIM: The primary aim of the TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE-65) trial is to assess the effects of an exercise and nutrition intervention on chemotherapy relative dose intensity among women aged ≥65 receiving chemotherapy for early-stage breast cancer. METHODS/DESIGN: THRIVE-65 is a 2-arm parallel-group randomized controlled trial. The intervention includes two 30-45 min telehealth delivered resistance exercise sessions weekly, 90 min of unsupervised aerobic exercise weekly, and dietitian-guided high protein intake (1.2 g/kg/day)) delivered throughout the course of chemotherapy. The Health Education and Support control group receives a tablet with supportive care materials. Planned and observed chemotherapy dose and treatment schedule are recorded to assess relative dose intensity. Pre- and post- intervention assessments include patient reported outcomes, a geriatric assessment, dietary and physical activity measures, physical function and body composition. CONCLUSIONS: The THRIVE-65 trial is poised to answer a crucial scientific question: Can exercise and nutrition support improve chemotherapy tolerance among older breast cancer patients? Study results will inform clinical practice related to exercise and nutrition support for this population.