An interventional study of Intervention group on diet and physical activity and Control group: only public recommendation an lifestyle in Breast Cancer Invasive, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed. Open to female participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Prevention
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).
Aims The investigators have been proposing a randomized intervention trial of diet and physical activity to reduce BC relapse (local, distant), and second ipsilateral or contralateral BC risk, in BC patients at high metabolic-endocrine of recurrence risk.
Secondary aims:
Recruitment:
Potential participants have been recruited at the time of diagnosis through follow-up clinics, patients' associations, or the media. Patients have been requested to sign an informed consent, including authorization for getting blood samples, for storing samples for future studies. The investigators collected demographic information, fasting measure body weight, height, waist circumference, and blood pressure, blood glucose, LDL and HDL cholesterol, triglycerides, testosterone and insulin. Eligible patients have filled in a baseline questionnaire on medical history, medication use, reproductive and body weight history, usual physical activity, and a validated semi-quantitative food frequency questionnaire.
Biological bank: the investigators collected and stored at -80°C one aliquot of whole blood, three 2-ml serum aliquot and two 2-ml buffy coat aliquot.
Randomization:
The investigators recruited 1542 patients' high risk and randomized the participants in two groups: 773 (control group) have received general standard written recommendation for healthy lifestyle without, however, any active support; 770 (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.
Randomization has been carried out within strata of age, treatment (no adjuvant therapy, chemotherapy only, hormonal therapy only, both hormonal and chemotherapy) and axillary nodal status at diagnosis.
Patients who did not satisfy the high-risk criteria have been given the same general recommendations as the control group, and have been followed up as an external low risk group.
Intervention:
The intervention wanted aim to increase physical activity, controlling weight, and promoting healthy diet.
Baseline and yearly measurements:
Height and weight: electronic scale with women in light clothes and without shoes. In a sample of cases body fat and lean mass will be measured with bioelectric impedance (BIA).
Blood pressure: electronic device. Serum glucose, triglycerides and cholesterol: standard quality-controlled laboratory techniques.
Serum Testosterone and Insulin: Radioimmunoassay (RIA). For testosterone the investigators have used a direct RIA kit which has been validated by comparison with indirect assay after organic extraction of serum samples and celite purification.
Compliance:
Compliance has been monitored through lifestyle questionnaires, dietary questionnaires, weight change and plasma glucose, triglycerides, cholesterol, insulin, testosterone changes after one year of intervention. A compliance score has been computed, based on the direction of change in all these biomarkers.
Follow-up and outcome events:
The main outcome is the new BC events including:
Statistical power:
The survival of BC patients in Italy is dramatically increasing: 5-year relative survival increased from 80.6% for patients diagnosed in the early 1990s to 85.6% for patients diagnosed in the early 2000s. For these patients the estimated relapse free survival is 81.9. Such a survival improvement is accompanied by a postponement of the incidence of relapse.
The original aim was to recruit 1,200 high risk patients in order to have 600 patients per arm, which shall guarantee 80% chance of getting a significant difference also with 25% reduction, and allowing for 90% compliance in the intervention group and 10% contamination of the control group.
Statistical analysis:
Nowadays the investigators are assessing the baseline association between androgens, insulin, and several measures of adiposity including body mass index (BMI), waist circumference and percentage body fat, through Spearman correlation coefficients. Furthermore, the investigators are comparing the change in food consumption, body weight, and geometric means of hormones end points from baseline to 12 months in the intervention and control group.
The main analysis of the intervention effect on the incidence of recurrences is by intention to treat, i.e. based on assigned treatment at the time of randomization, regardless of adherence. Later, as a secondary analysis the investigators shall assess the effect by change in body weight and biomarkers. The investigators shall compute total survival and disease-free survival.
Hazard ratios and confidence intervals will be computed by the Cox proportional hazard model, with standard clinic-pathological prognostic covariates as potential confounders. Separate analyses will be carried out by Estrogen Receptors, Progesterone Receptors and erbB2 status. The investigators decided to carry out another follow-up in 2022 as the relapse time has lengthened to 10 years, due to new therapies, and to evaluate the effects on lifestyle due to closures during the pandemia severe acute respiratory syndrome-CoV-2.
Feasibility:
The principal investigator (at first dr. Franco Berrino and later dr. Anna Villarini) has long term experience in carrying on and coordinating epidemiological studies, including small-scale dietary intervention studies. The Milano National Cancer Institute and the others collaborating center is fully equipped with facilities for kitchen courses and gym facilities.
Control of potential biases:
Performance bias-patients have been recruited after the main treatments have been planned or delivered. In no case the allocation to the intervention or control group or the compliance will affect treatment.
Measurement bias-patients and researchers cannot be blinded, but the ascertainment of outcome was carried out by clinicians that were not involved in the study.
Attrition bias-Based on previous studies the investigators expect a fairly high compliance in the intervention group (>90%) but also some modification in the control group. After the main analysis by intention to treat, therefore, secondary analyses will be carried out by compliance score.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,542 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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)
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
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.
Time frame: Baseline, fifth year
Modification lifestyle and Metabolic Syndrome (MetS)
The effect of the combined dietary and physical activity change on the prevalence of MetS (defined as the presence of three or more risk factors: waist circumference \>85 cm, systolic blood pressure \>130 mmhg and /or diastolic blood pressure \>85 mmhg), glycaemia \>100mg/100ml, triglycerides \>150 mg/100ml or HDL cholesterol \<50 mg/100ml) that is hypothesized to be intermediate factor in the association of diet and physical activity with BC recurrences.
Time frame: Baseline, first year
Modification lifestyle and Body Mass Index (BMI)
The effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (BMI \> 24.9 kg/m\^2) that is hypothesized to be intermediate factors in the association of diet and physical activity with BC recurrences.
Time frame: Baseline, first year
Modification lifestyle and Testosterone
The effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (testosterone \>= 0.4 ng/ml) that is hypothesized to be intermediate factors in the association of diet and physical activity with BC recurrences.
Time frame: Baseline, first year
Modification lifestyle and Insulin
The effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (insulin \> 50 pmol/L) that is hypothesized to be intermediate factors in the association of diet and physical activity with BC recurrences.
Time frame: Baseline, first year
Development other cancer
The effect of the intervention on the incidence of other cancers in all patients through the medical history reported in the medical record
Time frame: Baseline, fifth year
Development diabetes
The effect of the intervention on the incidence of diabetes in all patients through the medical history reported in the medical record
Time frame: Baseline, fifth year
Total mortality
The effect of the intervention on total mortality in all patients through the reference oncologists
Time frame: Baseline, fifth year
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The study protocol, dataset, statistical analysis plan, informed consent form and clinical study report were discussed through meetings held with all the collaborating centers. The individual participant data (IPD) were delivered to the coordinators of the individual centers in coded anonymous.
Supporting information: Study protocol, Sap, Icf, Csr
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano