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Completed

NCT Number: NCT03286257

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hot Flashes Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, L33AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.

Primary outcomes

  1. Change in Thermoregulation

    Time frame: 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.

  2. Change in Skin Blood Flow

    Time frame: 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.

Secondary outcomes

  1. Change in Cerebral Blood Flow

    Time frame: Change from pre- to post- 16 week exercise intervention

    Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.

  2. Change in Vascular Function

    Time frame: Change from pre- to post- 16 week exercise intervention

    Vascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change.

  3. Change in Vascular Structure

    Time frame: Change from pre- to post- 16 week exercise intervention

    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.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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