试验雷达 AI | ||
|---|---|---|
临床试验 NCT05848141 针对乳腺癌幸存者目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
佛罗里达大学Rowing Following Breast Cancer Chemotherapy
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“解释临床试验”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05848141是一项针对乳腺癌幸存者的干预性研究试验，目前试验状态为招募中。试验始于2024年2月26日，计划招募72名患者。该研究由佛罗里达大学主导，预计于2026年5月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年8月17日。
简要概括
There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.
官方标题
Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy
疾病
乳腺癌幸存者其他研究标识符
- IRB202201237
NCT编号
实际开始日期
2024-02-26
最近更新发布
2025-08-17
预计完成日期
2026-05-31
计划入组人数
72
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
主要目的
预防
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Indoor Rowing Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks. | 运动训练 This is a single site center-based supervised exercise intervention. |
无干预Usual Care Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments. | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in brachial FMD | Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. | Baseline, Following 12 weeks of supervised exercise training |
Change in global longitudinal strain | Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction. | Baseline, Following 12 weeks of supervised exercise training |
% completed vs. planned exercise frequency | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week. | Throughout the 12 weeks of supervised exercise training |
% completed vs. planned exercise duration | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session. | Throughout the 12 weeks of supervised exercise training |
% completed vs. planned exercise intensity | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session. | Throughout the 12 weeks of supervised exercise training |
Number of participants who experience adverse event as defined by most recent CTCAE | To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions. | Throughout the 12 weeks of supervised exercise training |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
40 Years
适龄性别
女性
- diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- female based on biological sex
- 40 to 80 years of age
- completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation
- absence of contraindications to exercise or study participation
- study clinician approval
- do not meet inclusion criteria
- receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation
- lymphedema stage ≥ 2 prior to study enrolment
- any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
- consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months
佛罗里达大学295 个活跃的临床试验可供探索研究中心联系人
联系人: Demetra Christou, PhD, 352-294-1746, [email protected]
1 位于 1 个国家/地区的研究中心
Florida
Integrative Cardiovasculal Physiology Laboratory, University of Florida, Gainesville, Florida, 32611, United States
Demetra Christou, PhD, 联系人, 352-294-1746, [email protected]
招募中