Background: Women with metastatic breast cancer (MBC) experience reduced quality-of-life and physical wellbeing. In early-stage breast cancer, sufficient physical activity and a healthy diet are associated with improved quality-of-life and survival, however, their importance for women with MBC is unclear. Our qualitative work with consumers has identified a lack of support for women with MBC compared to early-stage breast cancer, underpinning the need for MBC-specific supportive care, and led to the co-design of this program of research. The Optimising Care pilot study aimed to assess the feasibility, safety and efficacy of a combined exercise and dietary intervention for women with MBC.
Methods: Participants received a 16-week individually-tailored program delivered (eight Exercise Physiologist sessions [targeting ≥150 minutes of moderate-intensity, mixed-mode exercise]; eight Dietitian sessions [targeting protein intake: 1.0-1.5g/kg]), with assessment at baseline and end-of-intervention. Primary outcomes included intervention feasibility (retention, adherence, compliance) and safety (adverse events). Secondary outcomes were lean body mass (DXA), function (6-minute walk test, grip strength, 30-second sit-to-stand), quality-of-life (FACTB+4), fatigue (FACIT-F), anxiety and depression (HADS), and perceived stress (Perceived Stress Scale).
Results: 36 women participated (mean 57±9 years); 31 completed intervention (86%); and 23 completed end-of-intervention assessment (74%). Adherence to exercise and dietitian sessions was 86% (7±2 sessions), with an average of 187±82 minutes/week of exercise and no serious exercise-related adverse events. Statistically significant improvements were observed in the 6-minute walk test (p=0.01), 30-second sit-to-stand (p=0.01), and perceived stress (p=0.05) with no significant changes in the remaining secondary outcomes. Similar changes in outcomes were observed between those with and without disease progression.
Conclusion: Findings demonstrate that exercise is safe and feasible for women with MBC with combined exercise and dietary support potentially ameliorating the negative effects of MBC on body composition, quality-of-life, and functional and psychosocial outcomes. A Phase III trial will commence in 2023.