Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial

BMC Cancer

Study Protocol

Francesca Catalano¹  Giuseppe Banna¹  Cyril W.C. Kendall²  David J.A. Jenkins³  Massimo Libra⁴  Gabriele Riccardi⁵  Edward Vidgen⁶  Diego Serraino⁷  Samuele Massarut⁷  Ettore Bidoli⁷  Maria Grimaldi⁸  Michele De Laurentiis⁸  Ernesta Cavalcanti⁸  Monica Pinto⁸  Maurizio Montella⁸  Anna Crispo⁸  Massimiliano D’Aiuto⁸  Massimo Rinaldo⁸  Livia S.A. Augustin⁹  Gennaro Ciliberto^1,10  Davide Gatti^1,11  Rosalba Rossello^1,12  Francesco Ferrau’^1,12  Guglielmo Thomas^1,13 

[1] Cannizzaro Hospital, Catania, Italy;Clinical Nutrition and Risk Factor Modification Centre, St. Michael’s Hospital, Toronto, Canada;Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada;College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada;Clinical Nutrition and Risk Factor Modification Centre, St. Michael’s Hospital, Toronto, Canada;Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada;Division of Endocrinology and Metabolism, St. Michael’s Hospital, Toronto, Canada;Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Canada;Department of Biomedical and Biotechnological Sciences Oncologic, Clinical and General Pathology Section, University of Catania, Catania, Italy;Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy;Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada;National Cancer Institute CRO, Aviano, Italy;National Cancer Institute Istituto Nazionale Tumori “Fondazione Giovanni Pascale”, IRCCS, Naples, Italy;National Cancer Institute Istituto Nazionale Tumori “Fondazione Giovanni Pascale”, IRCCS, Naples, Italy;Clinical Nutrition and Risk Factor Modification Centre, St. Michael’s Hospital, Toronto, Canada;National Cancer Institute Istituto Nazionale Tumori “Fondazione Giovanni Pascale”, IRCCS, Naples, Italy;National Cancer Institute IRCCS Istituto Nazionale Tumori “Regina Elena”, Rome, Italy;Rheumatology Unit, University of Verona, Verona, Italy;San Vincenzo Hospital, Taormina, Italy;Seconda Universita’ di Napoli, Naples, Italy;Clinica Mediterranea SpA, Naples, Italy;

关键词: Dietary glycemic index;    Mediterranean diet;    Exercise;    Vitamin D;    Breast cancer recurrence;    Disease-free survival;    Cardiovascular disease;    Diabetes;    Risk factors;   

DOI  :  10.1186/s12885-017-3064-4

 received in 2016-09-21, accepted in 2017-01-13,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundMechanisms influencing breast cancer (BC) development and recurrence include hyperglycemia, hyperinsulinemia, high insulin-like growth factor-1, high circulating estrogen, inflammation and impaired cellular differentiation/apoptosis. A lifestyle program that targets all the above mechanisms may be warranted. Low glycemic index (GI) foods produce lower post-prandial glucose and insulin responses and have been associated with lower BC risk. Moderate physical activity post-diagnosis reduces BC recurrence and mortality, partly explained by reduced insulin and estrogen levels. Vitamin D increases cell differentiation/apoptosis and high serum vitamin D levels improve BC survival. Yet no trial has evaluated the combined effect of a low GI diet, moderate physical activity and vitamin D supplementation on BC recurrence in the context of a Mediterranean lifestyle setting.MethodsWomen (30-74 yr) who had undergone surgery for primary histologically confirmed BC (stages I-III) within the previous 12 months, in cancer centres in Italy, will be randomized to follow, for a maximum of 33 months, either a high intensity treatment (HIT) composed of low GI diet + exercise + vitamin D (60 ng/mL serum concentration) or a lower intensity treatment (LITE) with general advice to follow a healthy diet and exercise pattern + vitamin D to avoid insufficiency. Both interventions are on a background of a Mediterranean diet. Considering a 20% recurrence rate within 3 years for BC cases and a predicted rate of 10% in the HIT group, with power of 80% and two-sided alpha of 0.05, the subject number required will be 506 (n = 253 in each arm). Clinic visits will be scheduled every 3 months. Dietary and exercise counselling and vitamin D supplements will be given at each clinic visit when blood samples, anthropometric measures and 7-day food records will be collected.DiscussionDEDiCa study aims to reduce BC recurrence in women with BC using a lifestyle approach with additional vitamin D and to investigate possible cardio-metabolic benefits as well as epigenetic modifications according to lifestyle changes. Given the supporting evidence and safety of the components of our intervention we believe it is feasible and urgent to test it in cancer patients.Trial registrationMay 11, 2016; NCT02786875. EudraCT Number2015-005147-14

【 授权许可】

CC BY   
© The Author(s). 2017