Actively Recruiting

Age: 50Years - 70Years
FEMALE
ID03784651

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

Led by Rigshospitalet, Denmark · Updated on 2021-09-16

120

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

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 "Bone@BC" 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

Who Can Participate

Age: 50Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal
  • Breast cancer stage I-III
  • Eligible to receive (neo-)adjuvant chemotherapy or other antineoplastic treatment
  • Female aged 50 to 70 years
Not Eligible

You will not qualify if you...

  • Prior malignancy
  • Metabolic disease such as diabetes mellitus

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

Rigshospitalet

Copenhagen, Danmark, Denmark, 2100

Actively Recruiting

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Research Team

K

Kristian Buch, cand.med.

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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Published Research Related To This Trial

An observational study to examine changes in metabolic syndrome components in patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy.

Christina M Dieli-Conwright, Louise Wong, Sarah Waliany...

https://pubmed.ncbi.nlm.nih.gov/27219902

The development of the metabolic syndrome and insulin resistance after adjuvant treatment for breast cancer.

Emer M Guinan, Elizabeth M Connolly, Laura A Healy...

https://pubmed.ncbi.nlm.nih.gov/24088604

High insulin levels in newly diagnosed breast cancer patients reflect underlying insulin resistance and are associated with components of the insulin resistance syndrome.

Pamela J Goodwin, Marguerite Ennis, Mala Bahl...

https://pubmed.ncbi.nlm.nih.gov/18437560

Importance of metabolic changes induced by chemotherapy on prognosis of early-stage breast cancer patients: a review of potential mechanisms.

E Gadéa, E Thivat, E Planchat...

https://pubmed.ncbi.nlm.nih.gov/22133030

Guidance for the management of breast cancer treatment-induced bone loss: a consensus position statement from a UK Expert Group.

David M Reid, Julie Doughty, Richard Eastell...

https://pubmed.ncbi.nlm.nih.gov/18515009