Clinical trial NCT03286257: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Vascular function
Vascular structure
Thermoregulation
Hot flushes
Cerebral blood flow
Exercise training
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Thermoregulation
timeFrame: Change from pre- to post- 16 week exercise intervention
measure: Change in Skin Blood Flow
timeFrame: Change from pre- to post- 16 week exercise intervention
Secondary outcomes:
measure: Change in Cerebral Blood Flow
timeFrame: Change from pre- to post- 16 week exercise intervention
measure: Change in Vascular Function
timeFrame: Change from pre- to post- 16 week exercise intervention
measure: Change in Vascular Structure
timeFrame: Change from pre- to post- 16 week exercise intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Sciences (RISES)
state: Merseyside
Study officials:
affiliation: Professor
name: Helen Jones
role: STUDY_DIRECTOR
References: