title: Lifestyle and breast cancer recurrences: the DIANA-5 trial.
abstract: OBJECTIVE
  The DIANA (Diet and Androgens)-5 study is a multi-institutional randomized controlled trial of the effectiveness of a diet based on Mediterranean and macrobiotic recipes and principles, associated with moderate physical activity, in reducing additional breast cancer events in women with early stage invasive breast cancer at high risk of recurrence because of metabolic or endocrine milieu. The intervention is expected to reduce serum insulin and sex hormones, which were associated with breast prognosis in previous studies.
  
  
  METHODS
  Between 2008 and 2010, the study randomly assigned 1208 patients to an intensive diet and exercise intervention or to a comparison group, to be followed-up through 2015. General lifestyle recommendations for the prevention of cancer are given to both groups, and the intervention group is being offered a comprehensive lifestyle intervention, including cooking classes, conferences, common meals and exercise sessions. Adherence assessments occurred at baseline and at 12 months and are planned at 36 and 60 months. They include food frequency diaries, anthropometric measures, body fat distribution assessed with impedance scale, one week registration of physical activity with a multisensor arm-band monitor, metabolic and endocrine blood parameters. Outcome breast cancer events are assessed through self report at semi annual meetings or telephone interview and are validated through medical record verification.
  
  
  RESULTS
  The randomized groups were comparable for age (51.8 years), proportion of ER-negative tumors (22%), axillary node metastasis (42%), reproductive variables, tobacco smoking, blood pressure, anthropometric measurements and hormonal and metabolic parameters.
  
  
  CONCLUSIONS
  DIANA-5 has the potential to establish whether a Mediterranean-macrobiotic lifestyle may reduce breast cancer recurrences. We will assess evidence of effectiveness, first by comparing the incidence of additional breast cancer events (local or distant recurrence, second ipsilateral or contralateral cancer) in the intervention and in the control group, by an intention-to-treat analysis, and second by analyzing the incidence of breast cancer events in the total study population by compliance assessment score.
authors.affiliation: Department of Predictive and Preventive Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Villarini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Pasanisi
authors.forename: Adele
authors.initials: A
authors.lastname: Traina
authors.forename: Maria Piera
authors.initials: MP
authors.lastname: Mano
authors.forename: Bernardo
authors.initials: B
authors.lastname: Bonanni
authors.forename: Salvatore
authors.initials: S
authors.lastname: Panico
authors.forename: Corrado
authors.initials: C
authors.lastname: Scipioni
authors.forename: Rocco
authors.initials: R
authors.lastname: Galasso
authors.forename: Adriana
authors.initials: A
authors.lastname: Paduos
authors.forename: Milena
authors.initials: M
authors.lastname: Simeoni
authors.forename: Elena
authors.initials: E
authors.lastname: Bellotti
authors.forename: Maggiorino
authors.initials: M
authors.lastname: Barbero
authors.forename: Giorgio
authors.initials: G
authors.lastname: Macellari
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Venturelli
authors.forename: Milena
authors.initials: M
authors.lastname: Raimondi
authors.forename: Eleonora
authors.initials: E
authors.lastname: Bruno
authors.forename: Giuliana
authors.initials: G
authors.lastname: Gargano
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fornaciari
authors.forename: Daniele
authors.initials: D
authors.lastname: Morelli
authors.forename: Ettore
authors.initials: E
authors.lastname: Seregni
authors.forename: Vittorio
authors.initials: V
authors.lastname: Krogh
authors.forename: Franco
authors.initials: F
authors.lastname: Berrino
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D050218:Body Fat Distribution; D001943:Breast Neoplasms / Q000097:blood / Q000453:epidemiology* / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D031204:Caloric Restriction; D015930:Diet Records; D038441:Diet, Mediterranean; D004734:Energy Metabolism; D015444:Exercise; D005260:Female; D012739:Gonadal Steroid Hormones / Q000097:blood; D006801:Humans; D007328:Insulin / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D007558:Italy / Q000453:epidemiology; D008019:Life Style; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control; D010349:Patient Compliance; D011379:Prognosis; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D055502:Secondary Prevention / Q000379:methods*
chemical_list: D015415:Biomarkers; D012739:Gonadal Steroid Hormones; D007328:Insulin; D007334:Insulin-Like Growth Factor I