Breast Cancer Clinical Trial
— REBECCA-OSTOfficial title:
Exploratory Evaluation of the Functional/Emotional Life Characteristics During the First Year of Ongoing Endocrine Adjuvant Treatment With Aromatase Inhibitors in Breast Cancer Patients With Reduced Bone Mineral Density
Exploratory evaluation of the Functional/Emotional Life characteristics during the first year of ongoing endocrine adjuvant treatment with Aromatase Inhibitors in Breast Cancer patients (BCP) with reduced Bone Mineral Density (BMD)
Status | Active, not recruiting |
Enrollment | 82 |
Est. completion date | June 30, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Before patient registration, written informed consent must be given according to national and local regulations. - Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization. - Be between 18 and 75 years of age. - Have increased life expectancy beyond the initial 3 months post-treatment initiation. - Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent. - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Exclusion Criteria: - Patients already diagnosed with Osteopenia/Osteoporosis and already receiving BMD treatment (bisphosphonates or denosumab) - Patients already diagnosed with osteopenia/osteoporosis who have already suffered a bone event related to decreased BMD - Patients that are not willing to sign an informed consent form |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Cristina Hernando |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density (BMD) | Chronic osteopenia, as a result of significant reduction of BMD, is expected to significantly negatively affect Functional Life characteristics in BCPs undergoing adjuvant endocrine aromatase inhibitors treatments in comparison to those with milder symptomatology.
The association of the long-term outcomes of the PROM Index with the trajectory of reduced BMD-related symptomatology, as well as the Functional Life Index progression will be examined as an estimate of the safety and the effectiveness of the aromatase inhibitor adjuvant endocrine therapy. It is expected that the severity of reduced BMD-related symptomatology is associated with further deterioration of the Functional Life Index. Units: gr/cm^2 |
1 year | |
Secondary | Adjuvant treatment compliance | Adjuvant treatment compliance estimation (scale scored from 1 to 10) | 1 year | |
Secondary | Weight | Weight measurement (kg) as part of the anthropometric examination | 1 year | |
Secondary | Height | Height measurement (cm) as part of the anthropometric examination | 1 year | |
Secondary | C-Telopeptide concentration | C-Telopeptide concentration (pg/mL) from the blood samples extracted over the course of the study | 1 year |
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