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

NCT03286257 | Completed

• 1 other identifier: 16/NW/0166
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from pre- to post- 16 week exercise intervention

Secondary Outcomes (3)

• Change in Cerebral Blood Flow

  Change from pre- to post- 16 week exercise intervention

• Change in Vascular Function

  Change from pre- to post- 16 week exercise intervention

• Change in Vascular Structure

  Change from pre- to post- 16 week exercise intervention

Study Arms (1)

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.

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

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

Exercise Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

Study Sites (1)

Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, L33AF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen Jones

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Physiology

Study Record Dates

• First Submitted: September 9, 2017
• First Posted: September 18, 2017
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)