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

Breast Neoplasms Clinical Trial

— PREDICOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02035631
• Other study ID #: PREDICOP
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 10, 2014
• Last updated: January 13, 2014
• Start date: January 2014
• Est. completion date: January 2022

Study information

• Verified date: January 2014
• Source: Institut Català d'Oncologia
• Contact: Antonio Agudo, MD-PhD
• Phone: +34 932607401
• Email: a.agudo[@]iconcologia.net
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrence

Intervention

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.
• 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).
• Minimal diet intervention
Some basic diet recommendations
• Minimal physical activity intervention
Some basic recommendations on physical activity

Locations

Country	Name	City	State
Spain	Fundació Institut d'Investigació Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Girona
Spain	Institut Catala d'Oncologia - L'Hospitalet	L'Hospitalet de llobregat	Barcelona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in biomarkers	Biomarkers related to: sex hormone profile,; dietary intake,; insulin resistance,; inflammation process; and any biomarker possibly related to the progression of the disease.	Baseline and one year	No
Primary	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	No
Secondary	Overall survival	Time between recruitment date and death date or end of 5-year follow-up which ever occurs first	5 years	No
Secondary	Disease free survival	Time between recruitment date and recurrence (local or distant) or death or end of 5-year follow-up which ever occurs first	5 years	No
Secondary	Quality of life	Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)	Baseline, one year and three years	No