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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L33AF
      • Research Institute for Sport and Exercise Sciences (RISES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Investigators: Study Director: Helen Jones, Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 9, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Thermoregulation; Exercise training; Vascular function; Cerebral blood flow; Hot flushes; Vascular structure
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hot Flashes
• Other Study ID Numbers: 16/NW/0166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No