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临床试验/NCT03286257
NCT03286257已完成不适用

Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?

Liverpool John Moores University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change in Thermoregulation

研究概览

简要总结

In brief, this study sets out to understand if exercise training can reduce the frequency and severity of hot flushes associated with breast cancer treatment.

详细描述

In detail, the aim of this research project is to investigate whether improving temperature control mechanisms including vascular function, with exercise training is beneficial in alleviating hot flushes in breast cancer patients and their associated quality of life symptoms. Participants will be recruited at least 3-months post breast cancer treatment (surgery, radio-therapy, chemotherapy). This time point has been chosen for this study to allow patients to fully engage in the exercise intervention following treatment. All participants will be asked to attend the laboratory at Liverpool John Moores University on 4 separate occasions; 2 visits pre- and 2 visits following the exercise intervention for data collection including measures of vascular health, physical activity, sedentary behaviour, and fitness. The investigators will also gain information on food intake and incidence of hot flushes across a 7-day period pre- and post the intervention.

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

性别
Female
接受健康志愿者

入选标准

  • Able to provide written informed consent
  • Pre-menopausal, Peri-menopausal or post-menopausal
  • >4 hot flushes per day
  • Treated with tamoxifen or aromatase inhibitor

排除标准

  • Uncontrolled or severe hypertension (blood pressure > 160/100 mm Hg)
  • Any previous injury preventing exercise
  • Type 1 or 2 diabetes
  • Anti-depressants
  • Currently undergoing chemotherapy or radiotherapy
  • Current smoker
  • Cannot readily read and understand English

结局指标

主要结局

Change in Thermoregulation

时间窗: Change from pre- to post- 16 week exercise intervention

Participants will wear a tube-lined suit that allows manipulation of skin temperature by heating the water passed through the tubes. Core temperature will be increased by 1 degree (monitored using a temperature pill) with sweat rate and skin temperature recordings taken at 5minute intervals across 1 hour of heating. Thermoregulation will be compared during this hour to that of the post-exercise intervention re-test.

Change in Skin Blood Flow

时间窗: Change from pre- to post- 16 week exercise intervention

The change in skin blood flow will be measured using laser Doppler probes at the forearm.

次要结局

  • Change in Cerebral Blood Flow(Change from pre- to post- 16 week exercise intervention)
  • Change in Vascular Structure(Change from pre- to post- 16 week exercise intervention)
  • Change in Vascular Function(Change from pre- to post- 16 week exercise intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helen Jones

Professor of Cardiovascular Physiology

Liverpool John Moores University

研究点 (2)

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