NCT06727487Recruiting
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Oct 2023
- Start date
- 15 Nov 2024
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- Universidad Pontificia Comillas
- Diseases
- Ovarian cancer
- NCT number
- NCT06727487
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Nov 2024 to the primary completion date, 15 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or other drug abuse (excluding smoking).
Other illness
- Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.
Other
- Presence of medical contraindications to perform physical exercise.
- Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Universidad Pontificia Comillas Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.