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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Institut Català d'Oncologia
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT02035631
First received: January 10, 2014
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Breast Neoplasms
Recurrence
Behavioral: Diet
Behavioral: Physical activity
Behavioral: Minimal diet intervention
Behavioral: Minimal physical activity intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • Time to local and distant recurrence [ Time Frame: 5 years from recruitment day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Time between recruitment date and death date or end of 5-year follow-up which ever occurs first

  • Disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, one year and three years ] [ Designated as safety issue: No ]
    Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)


Other Outcome Measures:
  • Changes in biomarkers [ Time Frame: Baseline and one year ] [ Designated as safety issue: No ]

    Biomarkers related to:

    • sex hormone profile,
    • dietary intake,
    • insulin resistance,
    • inflammation process
    • and any biomarker possibly related to the progression of the disease.


Estimated Enrollment: 2000
Study Start Date: January 2014
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035631

Contacts
Contact: Antonio Agudo, MD-PhD +34 932607401 a.agudo@iconcologia.net
Contact: Noemie Travier, MSc +34 932607401 ntravier@iconcologia.net

Locations
Spain
Fundació Institut d'Investigació Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Beatriz Cirauqui Cirauqui, MD    +34 934978925    bcirauqui@iconcologia.net   
Principal Investigator: Beatriz Cirauqui Cirauqui, MD         
Institut Catala d'Oncologia - L'Hospitalet Not yet recruiting
L'Hospitalet de llobregat, Barcelona, Spain, 08908
Contact: Antonio Agudo, MD    +34 932607401    a.agudo@iconcologia.net   
Principal Investigator: Antonio Agudo, MD         
Consorci Sanitari de Terrassa Not yet recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Maria Angeles Arcusa Lanza, MD    +34 937003612    aarcusa@cst.cat   
Principal Investigator: Maria Angeles Arcusa Lanza, MD         
Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Contact: Vanesa Ortega Cebrián, MD    +34 934894350    vortega@vhebron.net   
Principal Investigator: Vanesa Ortega Cebrián, MD         
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Not yet recruiting
Girona, Spain, 17003
Contact: Sonia Del Barco Berron, MD    +34 972225834    sdelbarco@iconcologia.net   
Principal Investigator: Sonia Del Barco Berron, MD         
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)
  More Information

No publications provided

Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT02035631     History of Changes
Other Study ID Numbers: PREDICOP
Study First Received: January 10, 2014
Last Updated: January 13, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Institut Català d'Oncologia:
Breast Neoplasms
Recurrence
Motor Activity
Diet
Quality of Life

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Recurrence
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014