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

NCT02035631 | Unknown Phase 3

• 1 other identifier: PREDICOP
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Neoplasms; Recurrence

Keywords

Breast Neoplasms; Recurrence; Motor Activity; Diet; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  5 years

• Disease free survival

  5 years

• Quality of life

  Baseline, one year and three years

Other Outcomes (1)

• Changes in biomarkers

  Baseline and one year

Study Arms (2)

Intervention

EXPERIMENTAL

Lifestyle intervention combining weight control, diet and physical activity

Behavioral: Diet; Behavioral: Physical activity

Minimal intervention

SHAM COMPARATOR

Minimal diet intervention and minimal physical activity intervention

Behavioral: Minimal diet intervention; Behavioral: Minimal physical activity intervention

Interventions

Diet BEHAVIORAL

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.

Intervention

Physical activity BEHAVIORAL

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).

Intervention

Minimal diet intervention BEHAVIORAL

Some basic diet recommendations

Minimal intervention

Minimal physical activity intervention BEHAVIORAL

Some basic recommendations on physical activity

Minimal intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (5)

Fundació Institut d'Investigació Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Institut Catala d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Girona, Girona, 17003, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Recurrence; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Agudo, MD-PhD

CONTACT

+34 932607401; a.agudo@iconcologia.net

Noemie Travier, MSc

CONTACT

+34 932607401; ntravier@iconcologia.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

ES (5)