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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent Pre-menopausal, Peri-menopausal or post-menopausal >4 hot flushes per day Female Treated with tamoxifen or aromatase inhibitor Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Participants will complete a partially supervised 4 month exercise program consisting of 3-5 sessions/week at a moderate intensity (40-75% heart rate (HR) reserve) at Liverpool Lifestyles gyms. Participants will be given free access to the Wellness Key System© when using the Lifestyles exercise equipment which allows researchers to remotely track the exercise intensity of participants accurately. | Behavioral: Exercise Intervention<br>* A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Thermoregulation | 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 from pre- to post- 16 week exercise intervention | 
| Change in Skin Blood Flow | The change in skin blood flow will be measured using laser Doppler probes at the forearm. | Change from pre- to post- 16 week exercise intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cerebral Blood Flow | Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow. | Change from pre- to post- 16 week exercise intervention | 
| Change in Vascular Function | Vascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change. | Change from pre- to post- 16 week exercise intervention | 
| Change in Vascular Structure | Vascular structure will be measured at the carotid artery using ultrasound imaging to clearly visualise the artery. The image will be adjusted so artery wall thickness can be clearly seen with a 30 second recording taken at 3 different angles. The average of the three angles will be calculated with results reported as change in millimetres. | Change from pre- to post- 16 week exercise intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training