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NCT Number: NCT02067481

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

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.

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Key information

Conditions

Breast Cancer Behavior Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Weight Loss

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Catalá de Oncología

Barcelona, L´Hospitalet de Llobregat, 08908, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight loss intervention

Behavioral

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.

Other names: Dietary and Physical Activity Intervention

Primary outcomes

  1. Weight loss

    Time frame: 3 months

    Loss 3% of the initial weight

Secondary outcomes

  1. Quality of life

    Time frame: 3 months

    EORTC QLQ-C30 and BR23 mean scores

Other outcomes

  1. Biomarkers

    Time frame: 3 months

    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

  2. Cardiorespiratory fitness

    Time frame: 3 months

    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. Dietary habits

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Institut Català d'Oncologia

Other

Registry information

Official study title

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

Acronym: PREDICOP-F

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2014
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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