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NCT03784651Recruiting

Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer

Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer - a 5-year Follow-up Study.

Source: ClinicalTrials.gov · Last updated 16 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
29 Jun 2018
Start date
17 Dec 2018
Primary completion date
Nov 2021
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
NCT number
NCT03784651

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 17 Dec 2018 to the primary completion date, Nov 2021
  • 1 site 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.

Other illness

  • Prior malignancy
  • Metabolic disease (diabetes mellitus etc)

Who the study is looking for

  • Postmenopausal
  • Breast cancer stage I-III
  • Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment

Age in the registry: 50 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.