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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03286257
Enrollment
8
Registered
2017-09-18
Start date
2016-04-01
Completion date
2018-07-01
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training

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.

Interventions

BEHAVIORALExercise Intervention

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

Sponsors

Liverpool John Moores University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in ThermoregulationChange from pre- to post- 16 week exercise interventionParticipants 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 FlowChange from pre- to post- 16 week exercise interventionThe change in skin blood flow will be measured using laser Doppler probes at the forearm.

Secondary

MeasureTime frameDescription
Change in Cerebral Blood FlowChange from pre- to post- 16 week exercise interventionChange in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.
Change in Vascular FunctionChange from pre- to post- 16 week exercise interventionVascular function will be measured via endothelial-dependent flow mediated dilation of the brachial artery and reported as a percentage change.
Change in Vascular StructureChange from pre- to post- 16 week exercise interventionVascular 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026