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Breast NeoplasmsPhase 3PREDICOPNCT02035631

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

A Phase 3 study testing Diet, Physical activity and Minimal diet intervention in people with Breast Neoplasms and Recurrence, run by Institut Català d'Oncologia at 5 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Neoplasms, Recurrence
What is being tested?
Diet, Physical activity and Minimal diet intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
5 sitesSpain
Study dates
Jan 2014to Jan 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

Antonio Agudo, MD-PhD contact

+34 932607401

a.agudo@iconcologia.net

Noemie Travier, MSc contact

+34 932607401

ntravier@iconcologia.net

5 sites in 1 country

Spain5 sites

  • Fundació Institut d'Investigació Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Beatriz Cirauqui Cirauqui, MD, +34 934978925, bcirauqui@iconcologia.net

    Beatriz Cirauqui Cirauqui, MD

  • Hospital Vall d'Hebron

    Barcelona, Barcelona, 08035

    Vanesa Ortega Cebrián, MD, +34 934894350, vortega@vhebron.net

    Vanesa Ortega Cebrián, MD

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

    Girona, Girona, 17003

    Sonia Del Barco Berron, MD, +34 972225834, sdelbarco@iconcologia.net

    Sonia Del Barco Berron, MD

  • Institut Catala d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Antonio Agudo, MD, +34 932607401, a.agudo@iconcologia.net

    Antonio Agudo, MD

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

    Maria Angeles Arcusa Lanza, MD, +34 937003612, aarcusa@cst.cat

    Maria Angeles Arcusa Lanza, MD

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Diet, Physical activity, Minimal diet intervention, Minimal physical activity intervention
Keywords
Breast Neoplasms, Recurrence, Motor Activity, Diet, Quality of Life
Medical subject headings
Breast Neoplasms, Recurrence, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DietBehavioural

    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 activityBehavioural

    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 interventionBehavioural

    Some basic diet recommendations

  • Minimal physical activity interventionBehavioural

    Some basic recommendations on physical activity

Study groups in NCT02035631
Study groupRoleWhat they receive
InterventionExperimentalLifestyle intervention combining weight control, diet and physical activity
Receives: Behavioral: Diet; Behavioral: Physical activity
Minimal interventionSham comparatorMinimal diet intervention and minimal physical activity intervention
Receives: Behavioral: Minimal diet intervention; Behavioral: Minimal physical activity intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years from recruitment day

Secondary outcomes (3)

  1. Overall survival

    Time between recruitment date and death date or end of 5-year follow-up which ever occurs first

    Measured: 5 years

  2. 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

    Measured: 5 years

  3. Quality of life

    Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)

    Measured: Baseline, one year and three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2022 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02035631
Sponsor's protocol ID
PREDICOP
Acronym
PREDICOP
Status last verified
Jan 2014
First submitted
10 Jan 2014
Last updated
14 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diet, Physical activity and Minimal diet intervention in people with Breast Neoplasms and Recurrence, run by Institut Català d'Oncologia at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Agudo, MD-PhD (+34 932607401, a.agudo@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to local and distant recurrence (time frame: 5 years from recruitment day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02035631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.

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