Prevention Of Breast Cancer Recurrence Through Weight Control, Diet, And Physical Activity Intervention (PREDICOP): Design Of An Ongoing Study
Noemie TRAVIER, Catalan Institute of Oncology, Spain
TRAVIER N. 1
, BUCKLAND G. 1
, ARCUSA A. 2
, CIRAUQUI B. 3
, DEL BARCO S. 4
, GARRIGÓS L. 5
, MARGELI M. 3
, MUÑOZ M. 6
, ORTEGA V. 7
, JAVIERRE C. 8
, MORENO F. 9
, PERNAS S. 9
, AGUDO A. 1
1 Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain
2 Department of Medical Oncology, Consorci Sanitari de Terrassa, Terrassa, Spain
3 Department of Medical Oncology-ICO, Hospital Germans Trias i Pujol, Badalona, Spain
4 Department of Medical Oncology-ICO, Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain
5 Department of Medical Oncology, Hospital del Mar, Barcelona, Spain
6 Department of Medical Oncology, Hospital Clínic, Barcelona, Spain
7 Department of Breast Cancer Oncology, Hospital Universitari Vall d’Hebrón, Barcelona, Spain
8 Department of Physiological Sciences II, School of Medicine, University of Barcelona, Barcelona, Spain
9 Breast Cancer Functional Unit, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain
Advances in screening and treatment have resulted in an increasing number of breast cancer (BC) survivors. However, because the 5-year recurrence risk still ranges between 10 and 20%, there is a need to investigate modifiable factors that could impact long-term prognosis. Current evidence suggests that adiposity and physical inactivity could be determinants of prognosis. Nevertheless, to date the only two published studies on lifestyle intervention and BC recurrence only used a dietary intervention and provided controversial results.
The main purpose of the study is to investigate the effect of a diet and exercise intervention on BC recurrence.
The PREDICOP study is a multicentric randomized trial carried out in Spain that aims to include 2108 women, aged 18 to 75, having recently completed standard treatment for a non-metastatic invasive BC. Participants randomised to the control group will receive usual care and those in the intervention group will additionally receive a one-year lifestyle program. This program will include one supervised nutrition class and two supervised exercise sessions of moderate-to-high intensity per week during the first six months and monthly reminding sessions thereafter. All participants will subsequently be followed-up for four years. Data will be analysed on an intention-to-treat basis using time-to-event analysis.
Before setting-up the PREDICOP study, a one-arm trial was implemented to assess participation and compliance of overweight/obese BC survivors to a 12-week lifestyle intervention involving diet and exercise and demonstrate the capacity of the intervention to induce weight loss. This study showed a high compliance (> 80% of scheduled sessions attended), a significant 7% weight reduction and improvements in perceived quality of life.
If this lifestyle intervention results in a reduction in BC recurrence or an improvement in overall health and quality of life among BC survivors, it will help develop new clinical guidelines for BC patients.
RETICC:RD12/0036/0018, AGAUR:2014SGR726, FIS:PI12/00335