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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

January 10, 2014
January 13, 2014
January 2014
January 2022   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02035631 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
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.
Same as current
 
Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Breast Neoplasms
  • Recurrence
  • 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).
  • Behavioral: Minimal diet intervention
    Some basic diet recommendations
  • Behavioral: Minimal physical activity intervention
    Some basic recommendations on physical activity
  • Experimental: Intervention
    Lifestyle intervention combining weight control, diet and physical activity
    Interventions:
    • Behavioral: Diet
    • Behavioral: Physical activity
  • Sham Comparator: Minimal intervention
    Minimal diet intervention and minimal physical activity intervention
    Interventions:
    • Behavioral: Minimal diet intervention
    • Behavioral: Minimal physical activity intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
2000
January 2022
January 2022   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact: Antonio Agudo, MD-PhD +34 932607401 a.agudo@iconcologia.net
Contact: Noemie Travier, MSc +34 932607401 ntravier@iconcologia.net
Spain
 
NCT02035631
PREDICOP
No
Institut Català d'Oncologia
Institut Català d'Oncologia
Not Provided
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)
Institut Català d'Oncologia
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP