Trial of Diet, Physical Activity and Breast Cancer Recurrences: the DIANA-5 Study

NCT05019989 | Completed

• 1 other identifier: INT 37/07
• Study Type: interventional
• Target: 1,542
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer Invasive

Keywords

Breast cancer; Diet; Physical activity; Recurrences

Outcome Measures

Primary Outcomes (1)

• Reduction of recurrences

  The investigators have been proposing a randomized intervention trial of diet and physical activity to change BC relapse (local, distant), and second ipsilateral or contralateral BC, in BC patients at high risk of recurrence because of biochemical markers of increased risk, namely high serum testosterone and/or high fasting insulin and/or metabolic syndrome. Several other markers of increased recurrence risk are available, such as cancer stage at diagnosis, histological grade, hormonal receptors and other gene expression profile. All these will be registered, but the investigators are specifically interested in markers of the host that can be modified through life-style.

  Baseline, fifth year

Secondary Outcomes (7)

• Modification lifestyle and Metabolic Syndrome (MetS)

  Baseline, first year

• Modification lifestyle and Body Mass Index (BMI)

  Baseline, first year

• Modification lifestyle and Testosterone

  Baseline, first year

• Modification lifestyle and Insulin

  Baseline, first year

• Development other cancer

  Baseline, fifth year

Study Arms (2)

Intervention group: on diet and physical activity

EXPERIMENTAL

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

Behavioral: Intervention group on diet and physical activity

Control group: only public recommendations on lifestyle

EXPERIMENTAL

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

Behavioral: Control group: only public recommendation an lifestyle

Interventions

Intervention group on diet and physical activity BEHAVIORAL

The intervention wanted to increase physical activity, controlling weight, promoting healthy diet. 1. Physical activity: achieve and maintain regular participation in a moderate intensity physical activity program of 210 minutes/week (30 min on average per day) over at least 3 days /week; decrease sedentary behaviors by 30 minutes/day on at least 5 days/week 2. Weight control: reducing energy intake relative to expenditure is the primary dietary focus for promoting weight loss in overweight or obese participants, and maintaining a healthy energy balance is the primary focus for normal weight participants. Participants will be encouraged to include whole grains and high-fiber vegetables 3. Healthy diet: reducing calorie intake, through the preferred consumptions of unrefined cereals, pulses and vegetables, reducing high glycemic index food and high insulinemic foods, such as sugar and milk; reducing sources of saturated fat and animal protein (except fish)

Intervention group: on diet and physical activity

Control group: only public recommendation an lifestyle BEHAVIORAL

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

Control group: only public recommendations on lifestyle

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: Women breast cancer diagnosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator
• European Institute of Oncology: collaborator
• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: collaborator
• Federico II University: collaborator
• IRCCS Cancer Referral Center of Basilicata: collaborator
• ARNAS Civico Di Cristina Benfratelli Hospital: collaborator
• Lega Italiana per la Lotta contro i Tumori: collaborator
• Azienda Socio Sanitaria Territoriale di Mantova: collaborator
• Ministero della Salute, Italy: collaborator

Related Publications (7)

• Roveda 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 RESULT

• Roveda 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 RESULT

• Bruno 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 RESULT

• Berrino 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 RESULT

• Villarini 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 RESULT

• Djuric 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.

  PMID: 41483481 DERIVED

• De Santi M, Annibalini G, Marano G, Biganzoli G, Venturelli E, Pellegrini M, Lucertini F, Brandi G, Biganzoli E, Barbieri E, Villarini A. Association between metabolic syndrome, insulin resistance, and IGF-1 in breast cancer survivors of DIANA-5 study. J Cancer Res Clin Oncol. 2023 Sep;149(11):8639-8648. doi: 10.1007/s00432-023-04755-6. Epub 2023 Apr 27.

  PMID: 37106164 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Recurrence

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ANNA VILLARINI, PhD

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologist, Nutritionist, PhD and Senior researcher

Model Details: Randomized Trial of Diet, Physical Activity and Breast Cancer Recurrences. The investigators recruited 1542 patients' high risk and randomized them in two groups: 773 (control group) have received general standard written recommendation for healthy lifestyle without, however, any active support; 769 (intervention group) 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 and life-style change.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 25, 2021
• Study Start: June 1, 2008
• Primary Completion: September 30, 2012
• Study Completion: September 30, 2017
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be become available from baseline up to 10 years after study the end of recruitment (2027) for all coordinators of collaborating centers
• Access Criteria: The data are available on the National Cancer Institute of MILANO (Foundation-Institute of Hospitalization and Scientific Care), network managed