title: Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.
abstract: Mechanisms 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.
  
  
  
  Women (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.
  
  
  
  DEDiCa 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.
  
  
  
  May 11, 2016; NCT02786875 .
  
  
  
  2015-005147-14.
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy. livia.augustin@utoronto.ca.|Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada. livia.augustin@utoronto.ca.
authors.forename: Livia S A
authors.initials: LS
authors.lastname: Augustin
authors.affiliation: Department of Biomedical and Biotechnological Sciences Oncologic, Clinical and General Pathology Section, University of Catania, Catania, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Libra
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Crispo
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Grimaldi
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: De Laurentiis
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Rinaldo
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: D'Aiuto
authors.affiliation: Cannizzaro Hospital, Catania, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Catalano
authors.affiliation: Cannizzaro Hospital, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Banna
authors.affiliation: San Vincenzo Hospital, Taormina, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferrau'
authors.affiliation: San Vincenzo Hospital, Taormina, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Rossello
authors.affiliation: National Cancer Institute CRO, Aviano, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Serraino
authors.affiliation: National Cancer Institute CRO, Aviano, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Bidoli
authors.affiliation: National Cancer Institute CRO, Aviano, Italy.
authors.forename: Samuele
authors.initials: S
authors.lastname: Massarut
authors.affiliation: Seconda Universita' di Napoli, Naples, Italy.|Clinica Mediterranea SpA, Naples, Italy.
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Thomas
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Gatti
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Ernesta
authors.initials: E
authors.lastname: Cavalcanti
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Pinto
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Riccardi
authors.affiliation: Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Vidgen
authors.affiliation: 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.
authors.forename: Cyril W C
authors.initials: CW
authors.lastname: Kendall
authors.affiliation: 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.
authors.forename: David J A
authors.initials: DJ
authors.lastname: Jenkins
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.|National Cancer Institute IRCCS Istituto Nazionale Tumori "Regina Elena", Rome, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Ciliberto
authors.affiliation: National Cancer Institute Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Naples, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Montella
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000178:diet therapy* / Q000473:pathology; D038441:Diet, Mediterranean; D018572:Disease-Free Survival; D005081:Exercise Therapy; D005260:Female; D038321:Glycemic Index; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012307:Risk Factors; D016896:Treatment Outcome
keywords: Breast cancer recurrence; Cardiovascular disease; Diabetes; Dietary glycemic index; Disease-free survival; Exercise; Mediterranean diet; Risk factors; Vitamin D