Clinical trial · Interventional
Trial of Diet, Physical Activity and Breast Cancer Recurrences: the DIANA-5 Study
DIANA-5: Randomized Trial to Test the Efficacy of Dietary Change and Physical Activity to Prevent or Delay the Development of Recurrences in Breast Cancer Patients Estimated to be at High Risk of Recurrence Hormonal and Metabolic Reasons
NCT05019989CI-TRIAL-00053526DIANA-5completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators recruited 1542 Breast Cancer (BC) patients and to randomize the participants in two groups: 773 have received standard recommendations for healthy lifestyle without, however, any active support; 700 have received a combination of individual and group contacts over the course of one year, including kitchen courses, gym and dance classes, common meals and reinforcing meetings, with emphasis on a comprehensive dietary change including low saturated fat and low refined carbohydrates, and high whole grain cereals and pulses consumption. Compliance have been monitored through weight change and plasma glucose, triglycerides, cholesterol and testosterone. The main analysis will be by intention to treat. Under the hypothesis of reducing recurrence rate by 25% or 33% the statistical power of the study is 80% or, respectively, 90%, (P\<0.05, 5-year follow-up).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Invasive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group: only public recommendation an lifestyle | Behavioral | — | UNRESOLVED |
| Intervention group on diet and physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group: on diet and physical activity
- description
- Individual advice on diet and on physical activity Kitchen courses to teach basic Mediterranean and macrobiotic recipes (two 1-day course plus ten 3-h courses associated with common dinner) (15-20 participants at a time) Fortnightly common lunch or dinner (50-60 participant at a time) Basic gymnastic course (twelve - monthly- 2-hour courses) * Study newsletter, with scientific information, kitchen recipes, study facilities * Periodic conferences on diet and health * Periodic reinforcement meetings with common meals, gymnastic sessions, and dancing, after the first year * Periodic body weight assessment (weekly self-measurement and monthly measurement at the study center) * Discounted rate for advanced kitchen courses * Psychological support groups
- interventionNames
- Behavioral: Intervention group on diet and physical activity
- type
- EXPERIMENTAL
- label
- Control group: only public recommendations on lifestyle
- description
- 1. Invitation leaflet, explaining the rationale of the study and including basic life-style recommendations, based on the 1997 World Cancer Research Fund recommendations (to be updated in 2007) and the Italian National Institute of Nutrition food pyramid. 2. Dissemination of the information on the study by media 3. Yearly follow-up questionnaire on breast events and dietary and physical activity chang
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Mastectomy or conservative surgery for invasive breast cancer, any type, in the last five years (the investigators recruited mostly patients at the time or after surgery, when chemotherapy has been concluded and hormonal therapy, if necessary, has been started) * Absence of signs or symptoms suggestive of recurrences * Presence of one or more of the following endocrine/metabolic indicators: serum testosterone level ≥ 0.4 ng/ml (1 nmol/ml), corresponding to the median value in BC patients, or serum insulin ≥ 50 pmol/L, corresponding to the upper quartile of insulin distribution in Breast Cancer patients, or metabolic syndrome, present in about 15% of Breast Cancer patients. Exclusion Criteria: * Metastatic disease or previous relapse * Age \>70 * Physical or mental handicaps that would have impeded to engage in moderate physical activity or participate in kitchen classes
References
Publications (7)
- RESULTRoveda E, Bruno E, Galasso L, Mule A, Castelli L, Villarini A, Caumo A, Esposito F, Montaruli A, Pasanisi P. Rest-activity circadian rhythm in breast cancer survivors at 5 years after the primary diagnosis. Chronobiol Int. 2019 Aug;36(8):1156-1165. doi: 10.1080/07420528.2019.1621330. Epub 2019 Jun 10. PMID 31177874
- RESULTRoveda E, Vitale JA, Bruno E, Montaruli A, Pasanisi P, Villarini A, Gargano G, Galasso L, Berrino F, Caumo A, Carandente F. Protective Effect of Aerobic Physical Activity on Sleep Behavior in Breast Cancer Survivors. Integr Cancer Ther. 2017 Mar;16(1):21-31. doi: 10.1177/1534735416651719. Epub 2016 Jun 1. PMID 27252076
- RESULTBruno E, Gargano G, Villarini A, Traina A, Johansson H, Mano MP, Santucci De Magistris M, Simeoni M, Consolaro E, Mercandino A, Barbero M, Galasso R, Bassi MC, Zarcone M, Zagallo E, Venturelli E, Bellegotti M, Berrino F, Pasanisi P. Adherence to WCRF/AICR cancer prevention recommendations and metabolic syndrome in breast cancer patients. Int J Cancer. 2016 Jan 1;138(1):237-44. doi: 10.1002/ijc.29689. Epub 2015 Jul 28. PMID 26175188
- RESULTBerrino F, Villarini A, Traina A, Bonanni B, Panico S, Mano MP, Mercandino A, Galasso R, Barbero M, Simeoni M, Bassi MC, Consolaro E, Johansson H, Zarcone M, Bruno E, Gargano G, Venturelli E, Pasanisi P. Metabolic syndrome and breast cancer prognosis. Breast Cancer Res Treat. 2014 Aug;147(1):159-65. doi: 10.1007/s10549-014-3076-6. Epub 2014 Aug 8. PMID 25104441
- RESULTVillarini A, Pasanisi P, Traina A, Mano MP, Bonanni B, Panico S, Scipioni C, Galasso R, Paduos A, Simeoni M, Bellotti E, Barbero M, Macellari G, Venturelli E, Raimondi M, Bruno E, Gargano G, Fornaciari G, Morelli D, Seregni E, Krogh V, Berrino F. Lifestyle and breast cancer recurrences: the DIANA-5 trial. Tumori. 2012 Jan-Feb;98(1):1-18. doi: 10.1177/030089161209800101. PMID 22495696
- DERIVEDDjuric O, Bonvicini L, Pellegrini M, Bruno E, Pasanisi P, Gargano G, Curtosi P, Berrino F, Giorgi Rossi P, Villarini A. Diet, body composition and metabolic and hormonal profile in women at high risk of breast cancer recurrence: A secondary mediation analysis of the DIANA-5 trial. Clin Nutr. 2026 Jan;56:106537. doi: 10.1016/j.clnu.2025.11.021. Epub 2025 Dec 4.