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Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors (PREDICOP-F)

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ClinicalTrials.gov Identifier: NCT02067481
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Weight loss intervention Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Arm Intervention/treatment
Experimental: Single-arm 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 (AP) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment.
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.
Other Name: Dietary and Physical Activity Intervention



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 3 months ]
    Loss 3% of the initial weight


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3 months ]
    EORTC QLQ-C30 and BR23 mean scores


Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067481


Locations
Spain
Instituto Catalá de Oncología
Barcelona, L´Hospitalet de Llobregat, Spain, 08908
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
Principal Investigator: Antonio Agudo, MsC PhD Institut Catalá de Oncología

Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT02067481     History of Changes
Other Study ID Numbers: PREDICOP-F
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Institut Català d'Oncologia:
Breast cancer
Survivors
Weight loss
Diet
Physical activity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases