Breast CancerNCT03286257
Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
A study testing Exercise Intervention in people with Breast Cancer, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research Institute for Sport and Exercise Sciences (RISES)
Liverpool, Merseyside, L33AF
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Exercise Intervention
- Keywords
- Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from pre- to post- 16 week exercise intervention
Secondary outcomes (3)
Change in Cerebral Blood Flow
Change in cerebral blood flow will be assessed using transcranial Doppler ultrasound to measure brain blood flow.
Measured: 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.
Measured: 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.
Measured: Change from pre- to post- 16 week exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Apr 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Jones, Liverpool John Moores University
- Investigators
- Helen Jones, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286257
- Sponsor's protocol ID
- 16/NW/0166
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2017
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
- ClinicalTrials.gov ID
- NCT03286257
- Acronym / sponsor ID
- 16/NW/0166
- Conditions
- Breast Cancer
- Keywords
- Vascular function, Vascular structure, Thermoregulation, Hot flushes, Cerebral blood flow, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionA partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week. | Behavioural | Exercise Intervention |
Primary outcome
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.
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.
3 secondary outcomes
Change in Cerebral Blood Flow
Time frame: Change from pre- to post- 16 week exercise intervention
Change in Vascular Function
Time frame: Change from pre- to post- 16 week exercise intervention
Change in Vascular Structure
Time frame: Change from pre- to post- 16 week exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Jones study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Breast Cancer, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thermoregulation (time frame: Change from pre- to post- 16 week exercise intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.