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

L.S.A. Augustin, M. Libra, A. Crispo, M. Grimaldi, M. De Laurentiis, M. Rinaldo, M. D'Aiuto, F. Catalano, G. Banna, F. Ferrau', R. Rossello, D. Serraino, E. Bidoli, S. Massarut, G. Thomas, D. Gatti, E. Cavalcanti, M. Pinto, G. Riccardi, E. VidgenC.W.C. Kendall, D.J.A. Jenkins, G. Ciliberto, M. Montella

Research output: Contribution to journalArticlepeer-review

Abstract

Background: 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. Methods: Women (30-74yr) who had undergone surgery for primary histologically confirmed BC (stages I-III) within the previous 12months, in cancer centres in Italy, will be randomized to follow, for a maximum of 33months, either a high intensity treatment (HIT) composed of low GI diet + exercise + vitamin D (60ng/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 3years 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 3months. 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. Discussion: 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. Trial registration: May 11, 2016; NCT02786875. EudraCT Number: 2015-005147-14 © 2017 The Author(s).
Original languageEnglish
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - 2017

Keywords

  • Breast cancer recurrence
  • Cardiovascular disease
  • Diabetes
  • Dietary glycemic index
  • Disease-free survival
  • Exercise
  • Mediterranean diet
  • Risk factors
  • Vitamin D
  • colecalciferol
  • microRNA
  • adult
  • aged
  • Article
  • blood chemistry
  • body mass
  • body weight
  • breast cancer
  • cancer recurrence
  • cancer staging
  • cancer surgery
  • cancer survival
  • controlled study
  • diet
  • disease free survival
  • female
  • follow up
  • gene expression
  • glycemic control
  • histopathology
  • human
  • human tissue
  • Italy
  • kinesiotherapy
  • lifestyle modification
  • low glycemic index diet
  • major clinical study
  • multicenter study
  • randomized controlled trial
  • risk reduction
  • treatment duration
  • vitamin supplementation
  • waist circumference
  • breast tumor
  • diet therapy
  • glycemic index
  • methodology
  • middle aged
  • pathology
  • patient selection
  • prevention and control
  • randomized controlled trial (topic)
  • risk factor
  • treatment outcome
  • tumor recurrence
  • Adult
  • Aged
  • Breast Neoplasms
  • Diet, Mediterranean
  • Disease-Free Survival
  • Exercise Therapy
  • Female
  • Glycemic Index
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Patient Selection
  • Randomized Controlled Trials as Topic
  • Research Design
  • Risk Factors
  • Treatment Outcome

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