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

Livia S.A. Augustin, Massimo Libra, Anna Crispo, Maria Grimaldi, Michele De Laurentiis, Massimo Rinaldo, Massimiliano D'Aiuto, Francesca Catalano, Giuseppe Luigi Banna, Francesco Ferrau', Rosalba Rossello, Diego Serraino, Ettore Bidoli, Samuele Massarut, Guglielmo Thomas, Davide Gatti, Ernesta Cavalcanti, Monica Pinto, Gabriele Riccardi, Edward VidgenCyril W C Kendall, David J A Jenkins, Gennaro Ciliberto, Maurizio Montella

Research output: Contribution to journalArticle

7 Citations (Scopus)

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

Original languageEnglish
Article number69
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Jan 23 2017

Fingerprint

Glycemic Index
Vitamin D
Clinical Trials
Exercise
Breast Neoplasms
Diet
Recurrence
Life Style
Ambulatory Care
Estrogens
Insulin
Apoptosis
Mediterranean Diet
Food
Hyperinsulinism
Somatomedins
Serum
Epigenomics
Hyperglycemia
Italy

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DediCa) : Design of a clinical trial. / Augustin, Livia S.A.; Libra, Massimo; Crispo, Anna; Grimaldi, Maria; De Laurentiis, Michele; Rinaldo, Massimo; D'Aiuto, Massimiliano; Catalano, Francesca; Banna, Giuseppe Luigi; Ferrau', Francesco; Rossello, Rosalba; Serraino, Diego; Bidoli, Ettore; Massarut, Samuele; Thomas, Guglielmo; Gatti, Davide; Cavalcanti, Ernesta; Pinto, Monica; Riccardi, Gabriele; Vidgen, Edward; Kendall, Cyril W C; Jenkins, David J A; Ciliberto, Gennaro; Montella, Maurizio.

In: BMC Cancer, Vol. 17, No. 1, 69, 23.01.2017.

Research output: Contribution to journalArticle

Augustin, LSA, Libra, M, Crispo, A, Grimaldi, M, De Laurentiis, M, Rinaldo, M, D'Aiuto, M, Catalano, F, Banna, GL, Ferrau', F, Rossello, R, Serraino, D, Bidoli, E, Massarut, S, Thomas, G, Gatti, D, Cavalcanti, E, Pinto, M, Riccardi, G, Vidgen, E, Kendall, CWC, Jenkins, DJA, Ciliberto, G & Montella, M 2017, 'Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DediCa): Design of a clinical trial', BMC Cancer, vol. 17, no. 1, 69. https://doi.org/10.1186/s12885-017-3064-4
Augustin, Livia S.A. ; Libra, Massimo ; Crispo, Anna ; Grimaldi, Maria ; De Laurentiis, Michele ; Rinaldo, Massimo ; D'Aiuto, Massimiliano ; Catalano, Francesca ; Banna, Giuseppe Luigi ; Ferrau', Francesco ; Rossello, Rosalba ; Serraino, Diego ; Bidoli, Ettore ; Massarut, Samuele ; Thomas, Guglielmo ; Gatti, Davide ; Cavalcanti, Ernesta ; Pinto, Monica ; Riccardi, Gabriele ; Vidgen, Edward ; Kendall, Cyril W C ; Jenkins, David J A ; Ciliberto, Gennaro ; Montella, Maurizio. / Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DediCa) : Design of a clinical trial. In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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T1 - Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DediCa)

T2 - Design of a clinical trial

AU - Augustin, Livia S.A.

AU - Libra, Massimo

AU - Crispo, Anna

AU - Grimaldi, Maria

AU - De Laurentiis, Michele

AU - Rinaldo, Massimo

AU - D'Aiuto, Massimiliano

AU - Catalano, Francesca

AU - Banna, Giuseppe Luigi

AU - Ferrau', Francesco

AU - Rossello, Rosalba

AU - Serraino, Diego

AU - Bidoli, Ettore

AU - Massarut, Samuele

AU - Thomas, Guglielmo

AU - Gatti, Davide

AU - Cavalcanti, Ernesta

AU - Pinto, Monica

AU - Riccardi, Gabriele

AU - Vidgen, Edward

AU - Kendall, Cyril W C

AU - Jenkins, David J A

AU - Ciliberto, Gennaro

AU - Montella, Maurizio

PY - 2017/1/23

Y1 - 2017/1/23

N2 - 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

AB - 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

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KW - Cardiovascular disease

KW - Diabetes

KW - Dietary glycemic index

KW - Disease-free survival

KW - Exercise

KW - Mediterranean diet

KW - Risk factors

KW - Vitamin D

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