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

NCT03784651 | Recruiting

• 1 other identifier: H-18016600
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fracture; Glucose, High Blood; Insulin Resistance; Blood Pressure, High; Cholesterolemia

Outcome Measures

Primary Outcomes (2)

• Bone Mineral Density

  Change in bone mineral density

  1-5 years

• Metabolic syndrome

  Change in number of patients with the metabolic syndrome

  1-5 years

Secondary Outcomes (3)

• Bone fracture

  1-5 years

• Insulin resistance

  1-5 years

• Glucose

  1-5 years

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• Prior malignancy
• Metabolic disease (diabetes mellitus etc)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Danmark, 2100, Denmark

RECRUITING

Related Publications (28)

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• Lindholm A, Abrahamsen ML, Buch-Larsen K, Marina D, Andersson M, Helge JW, Schwarz P, Dela F, Gillberg L. Pro-inflammatory cytokines increase temporarily after adjuvant treatment for breast cancer in postmenopausal women: a longitudinal study. Breast Cancer Res. 2024 Oct 16;26(1):142. doi: 10.1186/s13058-024-01898-3.

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• Christensen IB, Abrahamsen ML, Ribas L, Buch-Larsen K, Marina D, Andersson M, Larsen S, Schwarz P, Dela F, Gillberg L. Peripheral blood mononuclear cells exhibit increased mitochondrial respiration after adjuvant chemo- and radiotherapy for early breast cancer. Cancer Med. 2023 Aug;12(16):16985-16996. doi: 10.1002/cam4.6333. Epub 2023 Jul 13.

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Fractures, Bone; Insulin Resistance; Hypertension

Condition Hierarchy (Ancestors)

Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Schwarz, Prof, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Buch, cand.med.

CONTACT

29434376; buch.kristian@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: December 24, 2018
• Study Start: December 17, 2018
• Primary Completion: November 1, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

DK (1)