Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

Breast Cancer Clinical Trial

— PREDICOP-F  

Official title:

Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067481
• Other study ID #: PREDICOP-F
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2014
• Last updated: February 19, 2014
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Description:

Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female patients from the Catalan Institute of Oncology

• Aged 18 to 75

• Body mass index (BMI) of 25 kg•m-2 or more

• Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

Exclusion Criteria:

• First cancer, tumours of stage IIIB and above

• Morbid obesity (BMI =40 kg•m-2)

• Any condition that could not permit to follow the diet and PA intervention offered

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Weight loss intervention
This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.

Locations

Country	Name	City	State
Spain	Instituto Catalá de Oncología	Barcelona	L´Hospitalet de Llobregat

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	Biomarkers	Blood analysis: Biomarkers related to glucose, lipid profile, IGF1, reproductive hormones, leptin, adiponectin, carotenoids, inflammation markers, oxidative stress markers and hematologic parameters, will be analysed	3 months	No
Other	Cardiorespiratory fitness	To determine peak oxygen uptake (VO2peak), an incremental cycle-ergometer test with monitoring ECG will be performed by exercise physiologists after a 24h period without physical activity in the Physiology Department of the University of Barcelona	3 months	No
Other	Dietary habits	A validated food frequency questionnaire will be used, designed to capture dietary habits, 24-hour dietary recalls (covering week days and weekends) will be taken to calculate the patients' energy intake and nutritional profile.	3 months	No
Primary	Weight loss	Loss 3% of the initial weight	3 months	No
Secondary	Quality of life	EORTC QLQ-C30 and BR23 mean scores	3 months	No