Tracking Bone and Metabolic Changes Over 5 Years in Postmenopausal Women with Early Breast Cancer After Cancer Treatment
Led by Rigshospitalet, Denmark · Updated on 2021-09-16
120
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Breast cancer is the most common cancer among European women, with many survivors due to early diagnosis and improved treatments. This research aims to understand the biological and physiological changes in bone and metabolism that occur after neo-adjuvant treatments for early non-metastatic breast cancer. The study focuses on identifying markers that may help prevent cardiometabolic diseases such as type 2 diabetes, which can arise as side effects of cancer treatment.
The study will follow 120 postmenopausal women aged 50 to 70 with early breast cancer stages I to III who are eligible for chemotherapy or other cancer treatments. Participants will be monitored before, during, and up to five years after treatment. Examinations include bone mineral density scans, body composition measurements, blood tests for glucose, insulin, lipids, and inflammation markers, lung function tests, neuropathy assessments, urine collection, and questionnaires about diet, physical activity, and quality of life. An app called BoneBC will also be used to collect patient-reported data related to quality of life and side effects.
Throughout the study, participants will have regular visits every six months or yearly alongside routine care to perform these assessments. Researchers will track bone density, metabolic health, insulin resistance, and nerve function to understand treatment effects and risks. Blood and urine samples will also be stored for future molecular analyses. The study includes safety monitoring, and data privacy is strictly maintained. Participation lasts five years from diagnosis, providing valuable information to help prevent long-term metabolic complications after breast cancer treatment.
CONDITIONS
Brief Title
Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer
Research Team
K
Kristian Buch, cand.med.
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Eligible to receive (neo-)adjuvant chemotherapy or other antineoplastic treatment
Female aged 50 to 70 years
You will not qualify if you...
Prior malignancy
Metabolic disease such as diabetes mellitus
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 5 years
Participants are followed to assess bone metabolism, body composition, insulin resistance, neuropathy, bone mineral density, and lung function during and after adjuvant cancer treatments.
Visits every 6 or 12 months alongside routine healthcare visits
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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