NCT02035631|UnknownPhase 3
Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
PREDICOP
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PREDICOP
Sponsor study identifier
interventional
2,000
1 country
5
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 10, 2014
Actual (reported)January 14, 2014
Actual (reported)January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Overall survival
5 years
Disease free survival
5 years
Quality of life
Baseline, one year and three years
Changes in biomarkers
Baseline and one year
Lifestyle intervention combining weight control, diet and physical activity
Minimal diet intervention and minimal physical activity intervention
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.
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).
Fundació Institut d'Investigació Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Beatriz Cirauqui Cirauqui, MD
Fundació Institut d'Investigació Germans Trias i Pujol
Sonia Del Barco Berron, MD
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Vanesa Ortega Cebrián, MD
Hospital Vall d'Hebron
Maria Angeles Arcusa Lanza, MD
Consorci Sanitari de Terrassa
First Submitted
January 10, 2014
First Posted
January 14, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2022
Estimated (date passed)Some basic diet recommendations
Some basic recommendations on physical activity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Institut Catala d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Girona, Girona, 17003, Spain
Antonio Agudo, MD
Institut Català d'Oncología - L'Hospitalet (ICO)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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