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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-70
SponsorRigshospitalet, Denmark

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal

Breast cancer stage I-III

Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment

Disqualifiers

Prior malignancy

Metabolic disease (diabetes mellitus etc)

Trial population

Postmenopausal women age 50-70 years diagnosed with breast cancer stage I-III eligible to receive (neo-)adjuvant chemotherapy or other adjuvant antineoplastic treatments including trastuzumab and CKK4-6 inhibitors, AI and bisphosphonate. Exclusion criteria include prior malignancy, preexisting T2D or other metabolic disease. The women will be recruited via the Department of Oncology at Rigshospitalet, Denmark.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Bone Mineral Density

Change in bone mineral density

Time frame
1-5 years
2

Metabolic syndrome

Change in number of patients with the metabolic syndrome

Time frame
1-5 years

Secondary outcomes

1

Bone fracture

Change in number of fractures

Time frame
1-5 years
2

Insulin resistance

Change in insulin resistance

Time frame
1-5 years
3

Glucose

Change in blood glucose

Time frame
1-5 years

Other outcomes

Sponsors and contacts

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