Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer - a 5-year Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
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.
详细描述
Purpose and background Breast cancer is the most common cancer in Danish women, and has an average of 4,750 new cases a year (1). Patients treated for early (non-metastatic) breast cancer (EBC) comprise, due to earlier diagnosis and improved treatment, a large and growing group of cancer survivors. However, many patients experience treatment-related endocrine side-effects such as reduced bone mineral density (BMD), dyslipidemia, insulin resistance and hypertension increasing the risk of bone fractures as well risk of development of cardiometabolic disease including Type 2 diabetes (T2D).
The purpose of the study is to understand the underlying physiological and molecular mechanisms responsible for the chemotherapy-induced bone and cardiometabolic derangements to identify novel disease mechanisms as well as to identify potential biomarkers to be used for better prediction and prevention of metabolic disease.
Objectives:
In a cohort of women (n=120) with EBC to assess (WP1):
• Bone metabolism, body composition, insulin resistance, neuropathy, bone mineral density (BMD) and lung function before chemotherapy, after chemotherapy and during five years follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal
- •Breast cancer stage I-III
- •Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment
排除标准
- •Prior malignancy
- •Metabolic disease (diabetes mellitus etc)
结局指标
主要结局
Bone Mineral Density
时间窗: 1-5 years
Change in bone mineral density
Metabolic syndrome
时间窗: 1-5 years
Change in number of patients with the metabolic syndrome
次要结局
- Bone fracture(1-5 years)
- Insulin resistance(1-5 years)
- Glucose(1-5 years)
研究者
Kristian Buch
Principal investigator
Rigshospitalet, Denmark