Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Pressure, High | — | UNRESOLVED | — |
| Bone Fracture | — | UNRESOLVED | — |
| Cholesterolemia | — | UNRESOLVED | — |
| Glucose, High Blood | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Bone Mineral Density
- timeFrame
- 1-5 years
- description
- Change in bone mineral density
- measure
- Metabolic syndrome
- timeFrame
- 1-5 years
- description
- Change in number of patients with the metabolic syndrome
Secondary outcomes (3)
- measure
- Bone fracture
- timeFrame
- 1-5 years
- description
- Change in number of fractures
- measure
- Insulin resistance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (28)
- BACKGROUNDNissen MJ, Shapiro A, Swenson KK. Changes in weight and body composition in women receiving chemotherapy for breast cancer. Clin Breast Cancer. 2011 Mar;11(1):52-60. doi: 10.3816/CBC.2011.n.009. PMID 21421523
- BACKGROUNDDieli-Conwright CM, Wong L, Waliany S, Bernstein L, Salehian B, Mortimer JE. An observational study to examine changes in metabolic syndrome components in patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy. Cancer. 2016 Sep 1;122(17):2646-53. doi: 10.1002/cncr.30104. Epub 2016 May 24. PMID 27219902
- BACKGROUNDDemark-Wahnefried W, Winer EP, Rimer BK. Why women gain weight with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1993 Jul;11(7):1418-29. doi: 10.1200/JCO.1993.11.7.1418. PMID 8315439
- BACKGROUNDGuinan EM, Connolly EM, Healy LA, Carroll PA, Kennedy MJ, Hussey J. The development of the metabolic syndrome and insulin resistance after adjuvant treatment for breast cancer. Cancer Nurs. 2014 Sep-Oct;37(5):355-62. doi: 10.1097/NCC.0b013e3182a40e6d. PMID 24088604
- BACKGROUNDPeairs KS, Wolff AC, Olsen SJ, Bantug ET, Shockney L, Kantsiper ME, Carrino-Tamasi E, Snyder CF. Coordination of care in breast cancer survivors: an overview. J Support Oncol. 2011 Nov-Dec;9(6):210-5. doi: 10.1016/j.suponc.2011.06.008. PMID 22055890
- BACKGROUNDEwertz M, Jensen MB, Gunnarsdottir KA, Hojris I, Jakobsen EH, Nielsen D, Stenbygaard LE, Tange UB, Cold S. Effect of obesity on prognosis after early-stage breast cancer. J Clin Oncol. 2011 Jan 1;29(1):25-31. doi: 10.1200/JCO.2010.29.7614. Epub 2010 Nov 29. PMID 21115856
- BACKGROUNDGoodwin PJ, Ennis M, Bahl M, Fantus IG, Pritchard KI, Trudeau ME, Koo J, Hood N. High insulin levels in newly diagnosed breast cancer patients reflect underlying insulin resistance and are associated with components of the insulin resistance syndrome. Breast Cancer Res Treat. 2009 Apr;114(3):517-25. doi: 10.1007/s10549-008-0019-0. Epub 2008 Apr 25.