NCT03784651 Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer
| NCT ID | NCT03784651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Bone Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2018-12-17 |
| Primary Completion | 2021-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2018-12-17 with a primary completion date of 2021-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer is the most common cancer type in European women. Patients treated for early non-metastatic breast cancer comprise a growing group of survivors due to early diagnosis and improved treatment. Many of these survivors experience adverse effects such as decreased bone mineral density, derangement of metabolic markers (fat, glucose, insulin) and increased blood pressure. Increasing risk of bone fracture and cardiometabolic disease (eg. diabetes mellitus type 2). The purpose of this study is to identify mechanisms behind cardiometabolic changes that may be connected to the (neo-)adjuvant treatment. On top of this we hope to indentify potential biological markers that can help prevent development of metabolic disease. We will be recruiting 120 post-menopausal women age 50-70 with early breast cancer and 1-2 times a year for 5 years examine bone mineral density, body composition, glucose and fat metabolism and nerve damage. A questionnaire will be used to collect information on diet, physical activity and quality of life. Derudover anvendes spørgeskemaer til at indsamle information vedrørende. This new knowledge will help clinicians start adequate preventive measures to help patients avoid cardiometabolic disease secondary to cancer treatment.
Eligibility Criteria
Inclusion Criteria: * Postmenopausal * Breast cancer stage I-III * Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment Exclusion Criteria: * Prior malignancy * Metabolic disease (diabetes mellitus etc)
Contact & Investigator
Peter Schwarz, Prof, MD
PRINCIPAL INVESTIGATOR
Copenhagen University Hospital, Rigshospitalet
Frequently Asked Questions
Who can join the NCT03784651 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 70 Years, studying Bone Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03784651 currently recruiting?
Yes, NCT03784651 is actively recruiting participants. Contact the research team at buch.kristian@gmail.com for enrollment information.
Where is the NCT03784651 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT03784651 clinical trial?
NCT03784651 is sponsored by Copenhagen University Hospital, Rigshospitalet. The principal investigator is Peter Schwarz, Prof, MD at Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 120 participants.