⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT02035631

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Fundació Institut d'Investigació Germans Trias i Pujol, Badalona, Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet, L'Hospitalet de llobregat, Barcelona, Spain

Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain

Hospital Vall d'Hebron, Barcelona, , Spain

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Girona, , Spain

Contact Details

Name: Beatriz Cirauqui Cirauqui, MD

Affiliation: Fundació Institut d'Investigació Germans Trias i Pujol

Role: PRINCIPAL_INVESTIGATOR

Name: Sonia Del Barco Berron, MD

Affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Role: PRINCIPAL_INVESTIGATOR

Name: Vanesa Ortega Cebrián, MD

Affiliation: Hospital Vall d'Hebron

Role: PRINCIPAL_INVESTIGATOR

Name: Maria Angeles Arcusa Lanza, MD

Affiliation: Consorci Sanitari de Terrassa

Role: PRINCIPAL_INVESTIGATOR

Name: Antonio Agudo, MD

Affiliation: Institut Català d'Oncología - L'Hospitalet (ICO)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: