Basic recommendationsPhysical exerciseNutritional advicePsycho-oncological support
Basic recommendations: Daily basis activity counseling by WHO recommendations
Physical exercise: A complete program of active physical exercise of medium and high intensity
Nutritional advice: A complete program of nutritional counseling
Psycho-oncological support: A program related with a patient Psycho-oncological follow-up
Study summary
The goal of this clinical trial is to compare a combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized BC with ER and/or PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment.
The study's primary objectives are to evaluate the impact of the combined intervention on weight reduction and favorable modification of body composition in terms of reduction in body fat and increase in lean mass.
The secondary objectives aim to evaluate the impact of the combined intervention program on CRF, heart rate (HR), capillary lactate levels, upper and lower body strength, physical functionality, and patient-reported outcomes (PROs). (exercise level, asthenia, self-perception, anxiety and depression), blood count and biochemistry values that could be modified, nutritional situation, and side effects of treatments.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria:
* Women who have reached the age of majority and up to 45 years of age.
* Premenopausal status is defined clinically as a patient who maintains menstruation prior to the start of chemotherapy treatment if this has taken place.
* Confirmed histological diagnosis of infiltrating breast carcinoma with expression of ER and/or RP stage I to III.
* Loco-regional treatment with surgery and radiotherapy, if any, completed.
* Adjuvant treatment with drugs that suppress ovarian function (aLHRH) is ongoing and expected to be maintained for at least 4 months at the beginning of the study.
* Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-1.
* Ability to understand and agree to the Informed Consent in writing.
Exclusion Criteria:
* Presence of medical contraindications to perform physical exercise.
* Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.
* Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.
* Pregnancy or breastfeeding.
* Alcohol or other drug abuse (excluding smoking).
Primary outcome measure(s)
Combined intervention evaluation on weight control — 1 year A combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized breast cancer expressing estrogen receptors and progesterone receptors who receive adjuvant treatment. The psycho-oncological intervention program aims to increase motivation to adhere to the physical exercise program and nutritional recommendations and maintain long-term healthy lifestyle habits.
Combined intervention evaluation in body composition — 1 year The variables weight, kilograms, fat mass, lean mass, and extracellular water will be obtained with the Tanita BC-601 Gold scale, including an impedance meter. The height, waist, and hip circumferences will be obtained with a tape measure. These measurements are necessary for calculating the BMI and the waist-high index (measure in centimeters). Weight and height will be combined to report BMI in kg/m\^2 Units of measure: weight in kilograms, height in meters.
Trial sites (2)
Facility
City
Region
Status
Universidad Pontificia Comillas
Madrid
Spain
Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Spain
Recruiting
More Universidad Pontificia Comillas trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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