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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286257
• Other study ID #: 16/NW/0166
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2023
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

Behavioral:
• Exercise Intervention
A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.

Locations

Country	Name	City	State
United Kingdom	Research Institute for Sport and Exercise Sciences (RISES)	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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