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临床试验/NCT04416087
NCT04416087招募中不适用

Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Tumor blood flow

研究概览

简要总结

This research aims at investigating tumor blood flow response to acute exercise in human cancer patients. It is hypothesized and expected that acute exercise increases tumor blood flow, which could plausibly increase the efficacy of cancer treatment.

详细描述

Physical activity has been applied as an adjunctive therapy in the secondary prevention of many cancers, but very little is currently known clinically and mechanistically about the effects of physical activity and exercise on tumor itself. Based on recent evidence from pre-clinical studies, it is plausible to expect that changes in tumor blood flow and its heterogeneity, oxygenation, and metabolism due to exercise would increase the delivery of chemotherapy and other cancer drugs into the tumor increasing the efficacy of cancer treatment.

Twenty (20) newly diagnosed Breast cancer patients will be recruited to investigate whether these pre-clinical findings can be extended to humans to serve as an evidence-based proof-of-concept for the possible inclusion of exercise in the treatment of cancer during chemotherapy. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, supine bicycle exercise in a positron emission tomography (PET) scanner will be used to exercise Breast cancer patients. These experiments are additional measurements to their normal treatments, and no new interventional approaches will be conducted in this study.

The study consists of one fitness test assessment, and tumor blood flow measurements with PET at rest and during supine cycling exercise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed breast cancer

排除标准

  • abnormal fatigue, anemia, or physical dysfunction due to the disease

结局指标

主要结局

Tumor blood flow

时间窗: Tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. Tumor blood flow at rest and during supine cycling exercise will be measured on the same day.

Measured with PET and radiowater (\[(15)O\]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.

次要结局

  • Spatial dispersion (heterogeneity) of tumor blood flow(The heterogeneity of tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. The heterogeneity of tumor blood flow at rest and during supine cycling exercise will be measured on the same day.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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