Actively Recruiting
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
Led by Universidad Pontificia Comillas · Updated on 2024-12-11
30
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
Universidad Pontificia Comillas
Lead Sponsor
H
Hospital General Universitario Gregorio Marañon
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Premenopausal status with menstruation prior to chemotherapy start
- Confirmed infiltrating breast carcinoma with ER and/or PR expression, stage I to III
- Completed loco-regional treatment with surgery and radiotherapy if applicable
- Ongoing adjuvant ovarian function suppression treatment (aLHRH) expected for at least 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ability to understand and provide written informed consent
You will not qualify if you...
- Medical contraindications to performing physical exercise
- Meeting any American Thoracic Society (ATS) criteria preventing cardiovascular capacity testing
- Presence of active cancer including metastatic breast cancer or other tumors
- Pregnancy or breastfeeding
- Alcohol or drug abuse (excluding smoking)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Universidad Pontificia Comillas
Madrid, Spain, 28015
Actively Recruiting
2
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Actively Recruiting
Research Team
J
Julio C de la Torre-Montero, Ph.D
CONTACT
M
Maria Jesús Martínez Beltrán, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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