Clinical trial NCT02035631: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
Official title: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Neoplasms
Recurrence
Keywords: Breast Neoplasms
Recurrence
Motor Activity
Diet
Quality of Life
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Time to local and distant recurrence
timeFrame: 5 years from recruitment day
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Quality of life
timeFrame: Baseline, one year and three years
Other outcomes:
measure: Changes in biomarkers
timeFrame: Baseline and one year
Locations:
city: Badalona
country: Spain
facility: Fundació Institut d'Investigació Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de llobregat
country: Spain
facility: Institut Catala d'Oncologia - L'Hospitalet
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Girona
country: Spain
facility: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study officials:
affiliation: Fundació Institut d'Investigació Germans Trias i Pujol
name: Beatriz Cirauqui Cirauqui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Sonia Del Barco Berron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron
name: Vanesa Ortega Cebrián, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci Sanitari de Terrassa
name: Maria Angeles Arcusa Lanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català d'Oncología - L'Hospitalet (ICO)
name: Antonio Agudo, MD
role: PRINCIPAL_INVESTIGATOR
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