The Effect of Diet on Breast Cancer Recurrence: The DIANA-5 Randomized Trial

Author:

Berrino Franco12ORCID,Villarini Anna3ORCID,Gargano Giuliana1ORCID,Krogh Vittorio1ORCID,Grioni Sara1ORCID,Bellegotti Manuela1ORCID,Venturelli Elisabetta4ORCID,Raimondi Milena1ORCID,Traina Adele5ORCID,Zarcone Maurizio5ORCID,Amodio Rosalba5ORCID,Mano Maria Piera67ORCID,Johansson Harriet8ORCID,Panico Salvatore9ORCID,Santucci de Magistris Maria10ORCID,Barbero Maggiorino11ORCID,Gavazza Cristina12ORCID,Mercandino Angelica13ORCID,Consolaro Elena14ORCID,Galasso Rocco15ORCID,Del Riccio Luciana15ORCID,Bassi Maria Chiara16ORCID,Simeoni Milena17ORCID,Premoli Paolo17ORCID,Pasanisi Patrizia4ORCID,Bonanni Bernardo8ORCID,Bruno Eleonora4ORCID

Affiliation:

1. 1Department of Epidemiology and Data Science, S.C. Epidemiology and Prevention, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.

2. 2La Grande Via Foundation, Milan, Italy.

3. 3Department of Medicine and Surgery, Section of Hygiene and Public Health, University of Perugia, Perugia, Italy.

4. 4Department of Experimental Oncology, S.S.D. Nutrition Research and Metabolomics, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.

5. 5Palermo and Province Cancer Registry, Clinical Epidemiology Unit with Cancer Registry, Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone”, University of Palermo, Palermo, Italy.

6. 6Dipartimento Scienze Chirurgiche, Study University, Turin, Italy.

7. 7S.C. Epidemiologia dei Tumori, AOU Città della Salute e della Scienza, CPO Piemonte, Turin, Italy.

8. 8Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.

9. 9School of Medicine, Federico II University, Naples, Italy.

10. 10A.O.U. Federico II, Naples, Italy.

11. 11Obstetrics and Gynecology Unit, Cardinal Massaia Hospital, Asti, Italy.

12. 12LILT, Associazione Provinciale di Asti O.D.V, Italy.

13. 13Fondazione Edo ed Elvo Tempia ONLUS, Biella, Italy.

14. 14ATS Insubria, Varese, Italy.

15. 15Unit of Regional Cancer Registry, Clinical Epidemiology and Biostatistics, IRCCS-CROB, Rionero in Vulture, Italy.

16. 16ATS Valpadana, Mantova area, Italy.

17. 17LUMEN Aps, San Pietro in Cerro (Piacenza), Italy.

Abstract

Abstract Purpose: The DIANA-5 randomized controlled trial assessed the effectiveness of a diet based on Mediterranean and macrobiotic traditions (macro-Mediterranean diet) in reducing breast cancer recurrence. Patients and Methods: The DIANA-5 study involved 1,542 patients with breast cancer at high risk of recurrence because of estrogen receptor–negative cancer, or metabolic syndrome, or high plasma levels of insulin or testosterone. Women were randomly assigned to an active dietary intervention (IG) or a control group (CG). Both groups received the 2007 American Institute for Cancer Research/World Cancer Research Fund recommendations for cancer prevention. The intervention consisted of meetings with kitchen classes, community meals, and dietary recommendations. Recommended foods included whole grain cereals, legumes, soy products, vegetables, fruit, nuts, olive oil, and fish. Foods to be avoided were refined products, potatoes, sugar and desserts, red and processed meat, dairy products, and alcoholic drinks. A compliance Dietary Index was defined by the difference between recommended and discouraged foods. Results: Over the 5 years of follow-up, 95 patients of the IG and 98 of the CG developed breast cancer recurrence [HR = 0.99; 95% confidence interval (CI): 0.69–1.40]. The analysis by compliance to the dietary recommendations (IG and CG together) showed that the women in the upper tertile of Dietary Index change had an HR of recurrence of 0.59 (95% CI: 0.36–0.92) compared with women in the lower tertile. Conclusions: The DIANA-5 dietary intervention trial failed to show a reduction in breast cancer recurrence, although self-reported diet at year 1 in IG and CG combined showed a protective association with the higher Dietary Index change.

Publisher

American Association for Cancer Research (AACR)

Subject

Cancer Research,Oncology

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