Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training
Eligibility Criteria
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
Sites / Locations
- Research Institute for Sport and Exercise Sciences (RISES)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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 in Skin Blood Flow
The change in skin blood flow will be measured using laser Doppler probes at the forearm.
Secondary Outcome Measures
Change in Cerebral Blood Flow
Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.
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 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.
Full Information
NCT ID
NCT03286257
First Posted
September 9, 2017
Last Updated
October 10, 2023
Sponsor
Liverpool John Moores University
1. Study Identification
Unique Protocol Identification Number
NCT03286257
Brief Title
Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
Official Title
Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.
Primary Outcome Measure Information:
Title
Change in Thermoregulation
Description
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.
Time Frame
Change from pre- to post- 16 week exercise intervention
Title
Change in Skin Blood Flow
Description
The change in skin blood flow will be measured using laser Doppler probes at the forearm.
Time Frame
Change from pre- to post- 16 week exercise intervention
Secondary Outcome Measure Information:
Title
Change in Cerebral Blood Flow
Description
Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.
Time Frame
Change from pre- to post- 16 week exercise intervention
Title
Change in Vascular Function
Description
Vascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change.
Time Frame
Change from pre- to post- 16 week exercise intervention
Title
Change in Vascular Structure
Description
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.
Time Frame
Change from pre- to post- 16 week exercise intervention
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Jones
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute for Sport and Exercise Sciences (RISES)
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L33AF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
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