Weight, Body Composition And Biological Changes After A 6-Month Adapted Physical Activity Program During Adjuvant Treatment For Localized Breast Cancer: A Randomized Controlled Trial
Marina TOUILLAUD, Léon Bérard Cancer Centre, France
FOUCAUT A. 1,2
, MORELLE M. 3
, BERTHOUZE S. 4
, TRÉDAN O. 5
, FERVERS B. 1
, BACHMANN P. 6
1 Dpt of Cancer and Environment, Léon Bérard Cancer Centre, Lyon, France
2 Educations and Health Practices Laboratory EA 3412, Paris 13 University Sorbonne Paris Cité, Bobigny, France
3 Direction of Clinical Research and of Innovation, Léon Bérard Cancer Center, Lyon, France
4 Centre for Research and Innovation on Sport EA647, Claude Bernard Lyon 1 University, Villeurbanne, France
5 Dpt of Medical Oncology, Léon Bérard Cancer Centre, Lyon, France
6 Nutrition Unit-DISSPO, Léon Bérard Cancer Centre, Lyon, France
Purpose: After a breast cancer (BC) diagnosis, weight gain and loss of physical fitness are negative prognostic factors. In contrast, healthy diet and regular physical activity (PA) might prevent comorbidity and mortality. The randomized controlled trial PASAPAS (www.clinicaltrials.gov, no.NCT01331772) was designed to evaluate the feasibility of a 6-month adapted PA program concomitant to adjuvant chemotherapy in early-stage BC patients.
Methods: 61 patients were recruited between 2011 and 2013 and randomly allocated between an intervention and a control arm (2:1 ratio). All participants benefited from dietetic counseling. The intervention arm was offered a 6-month aerobic exercise program of two to three weekly group sessions. Blood draw, anthropometrics, body composition and PA questionnaires were obtained at baseline and 6 months. Effects of exercise were investigated using correlation analyses.
Results: 60 (98%) of the patients completed the study and one patient retrieved from the trial after randomization. At baseline, the intervention (n=41) and control (n=19) arms were similar in all aspects. In the intervention group, median adherence to the program was 85% of the sessions. Mains reasons for non-compliance were logistic and second or reconstructive surgery. After 6 months, there were no differences in anthropometrics, body composition and PA level between arms. However, most (>70%) women maintained or decreased their weight, waist circumference or fat mass, and maintained or increased their lean mass. The amount of moderate-to-vigorous (>4 METs) PA was inversely correlated with weight (p=.04) and body fat (p=.01) variations. Sedentary behavior was positively correlated with fasting glycemia (p=.04) and total cholesterol (p=.03) variations.
Conclusions: This study showed that implementing a 6-month exercise program is feasible during adjuvant chemotherapy for BC in a French population. It will serve as foundation for future randomized controlled trials of efficacy.
Funding sources: INCa, Ligue contre le cancer; Fondation de France, CLARA, French Ministry of Research