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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrence; Breast Neoplasms
• Intervention / Treatment: Behavioral: Diet; Behavioral: Physical activity; Behavioral: Minimal diet intervention; Behavioral: Minimal physical activity intervention

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Antonio Agudo, MD-PhD; Phone Number: +34 932607401; Email: a.agudo@iconcologia.net
• Study Contact Backup: Name: Noemie Travier, MSc; Phone Number: +34 932607401; Email: ntravier@iconcologia.net

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
    • Contact: Vanesa Ortega Cebrián, MD; Phone Number: +34 934894350; Email: vortega@vhebron.net
    • Principal Investigator: Vanesa Ortega Cebrián, MD
  • Girona, Spain, 17003
    • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
    • Contact: Sonia Del Barco Berron, MD; Phone Number: +34 972225834; Email: sdelbarco@iconcologia.net
    • Principal Investigator: Sonia Del Barco Berron, MD
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Fundació Institut d'Investigació Germans Trias i Pujol
      • Contact: Beatriz Cirauqui Cirauqui, MD; Phone Number: +34 934978925; Email: bcirauqui@iconcologia.net
      • Principal Investigator: Beatriz Cirauqui Cirauqui, MD
    • L'Hospitalet de llobregat, Barcelona, Spain, 08908
      • Institut Català d'Oncologia - L'Hospitalet
      • Contact: Antonio Agudo, MD; Phone Number: +34 932607401; Email: a.agudo@iconcologia.net
      • Principal Investigator: Antonio Agudo, MD
    • Terrassa, Barcelona, Spain, 08227
      • Consorci Sanitari de Terrassa
      • Contact: Maria Angeles Arcusa Lanza, MD; Phone Number: +34 937003612; Email: aarcusa@cst.cat
      • Principal Investigator: Maria Angeles Arcusa Lanza, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in biomarkers	Biomarkers related to: sex hormone profile,; dietary intake,; insulin resistance,; inflammation process; and any biomarker possibly related to the progression of the disease.	Baseline and one year

Collaborators and Investigators

• Sponsor: 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)

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Quality of Life; Recurrence; Diet; Breast Neoplasms; Motor Activity
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: PREDICOP