PREDICOP: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

Sponsor

Institut Català d'Oncologia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02035631

Collaborator

(none)

2,000

Enrollment

Locations

Arms

Duration (Months)

400

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Recurrence	Behavioral: Diet Behavioral: Physical activity Behavioral: Minimal diet intervention Behavioral: Minimal physical activity intervention	Phase 3

Detailed Description

BACKGROUND/MAIN OBJECTIVE: The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours. As secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. METHODOLOGY: This multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage I, II, IIIA) in the participating centres, whose standard treatment was completed within the last 3 months. Participants will be assigned to either an intervention or a control group, and followed for five years. Patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. Patients in the intervention group will be involved in a lifestyle program with two components. The dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. Data will be analyzed on an intention to treat basis using time-toevent analysis. HYPOTHESES: We expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. Furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Lifestyle intervention combining weight control, diet and physical activity	Behavioral: Diet The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals. Behavioral: Physical activity The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions).
Sham Comparator: Minimal intervention Minimal diet intervention and minimal physical activity intervention	Behavioral: Minimal diet intervention Some basic diet recommendations Behavioral: Minimal physical activity intervention Some basic recommendations on physical activity

Arm

Intervention/Treatment

Experimental: Intervention

Lifestyle intervention combining weight control, diet and physical activity

Behavioral: Diet

The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals.

Behavioral: Physical activity

The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions).

Sham Comparator: Minimal intervention

Minimal diet intervention and minimal physical activity intervention

Behavioral: Minimal diet intervention

Some basic diet recommendations

Behavioral: Minimal physical activity intervention

Some basic recommendations on physical activity

Outcome Measures

Primary Outcome Measures

Time to local and distant recurrence [5 years from recruitment day]
Time between recruitment date and local and distant recurrence date or end of the 5-year follow-up which ever occurs first

Secondary Outcome Measures

Overall survival [5 years]
Time between recruitment date and death date or end of 5-year follow-up which ever occurs first
Disease free survival [5 years]
Time between recruitment date and recurrence (local or distant) or death or end of 5-year follow-up which ever occurs first
Quality of life [Baseline, one year and three years]
Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)

Other Outcome Measures

Changes in biomarkers [Baseline and one year]
Biomarkers related to: sex hormone profile, dietary intake, insulin resistance, inflammation process and any biomarker possibly related to the progression of the disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

incident primary breast cancer (ICD-O C50)
stage at diagnosis I, II, IIIA (or T1-3, N0-N2, M0)
age at diagnosis below 76 years
within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease

Exclusion Criteria:

morbid obesity (BMI >40kg/m²) or underweight (BMI <18kg/m²)
ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months
diabetes (only if unstable - glycosylated haemoglobin >9%)
current medical or surgical treatment to lose weight
mental illness that would prevent the patient from carrying out the intervention
logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments)
pregnant or planning pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundació Institut d'Investigació Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	Institut Catala d'Oncologia - L'Hospitalet	L'Hospitalet de llobregat	Barcelona	Spain	08908
3	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain	08227
4	Hospital Vall d'Hebron	Barcelona		Spain	08035
5	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Girona		Spain	17003

Sponsors and Collaborators

Institut Català d'Oncologia

Investigators

Principal Investigator: Beatriz Cirauqui Cirauqui, MD, Fundació Institut d'Investigació Germans Trias i Pujol
Principal Investigator: Sonia Del Barco Berron, MD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Principal Investigator: Vanesa Ortega Cebrián, MD, Hospital Vall d'Hebron
Principal Investigator: Maria Angeles Arcusa Lanza, MD, Consorci Sanitari de Terrassa
Principal Investigator: Antonio Agudo, MD, Institut Català d'Oncología - L'Hospitalet (ICO)