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

NCT ID: NCT03286257

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-07-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Exercise Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Helen Jones

Professor of Cardiovascular Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Jones

Role: STUDY_DIRECTOR

Professor

Locations

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Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16/NW/0166

Identifier Type: -

Identifier Source: org_study_id

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