Study Stopped
Logistical problems meant that the study was no longer feasible.
Health Benefits of HIT for Breast Cancer Patients
The Efficacy of Reduced-exertion High-intensity Interval Training for Improving Health and Well-being in Newly Diagnosed Female Breast Cancer Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Treatment of cancer patients should not only involve removing the cancer, but should also focus on maintaining good health and well-being and quality of life. This can be done by offering patients suitable rehabilitation programmes. Previous research has shown that such programmes need to involve exercise alongside other components, such as psychological support. To date most studies have looked at the positive effects of moderate-intensity exercise such as brisk walking, but this type of exercise is time-consuming and often not done by many patients. Shorter-duration exercise routines consisting of repeated short sprints have been found to improve general health just as well, but one of the most time-efficient routines (termed 'reduced-exertion high-intensity interval training', or 'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per week, each only 10 minutes long. This makes it an ideal routine to combine with other components of a cancer rehabilitation programme. The present study will determine whether REHIT can improve important markers of health and well-being in newly diagnosed breast cancer patients. To achieve this the investigators will recruit up to 30 patients and divide them into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a control group who will receive standard care. Markers of health and well-being will be measured at the start of the study, \~1 week after surgery, and \~7 weeks after surgery. Any changes will be compared between the exercise group and the control group. If beneficial effects are found with the REHIT intervention then this could be more widely implemented as part of cancer treatment. This study is funded by Nuffield Health and will be performed in Oxford, UK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2019
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 25, 2020
March 1, 2020
8 months
May 29, 2017
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in maximal aerobic capacity (VO2max)
VO2max is a measure of the maximal amount of exercise that can be consumed and used during exercise. It is one of the best predictors of future risk of morbidity and mortality. An increase in VO2max represents a positive change in health. The primary outcome measure is change in VO2max from baseline to 1 week post-surgery and 7 weeks post-surgery.
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
Secondary Outcomes (7)
Change in homeostatic model assessment of insulin resistance (HOMA-IR)
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
Change in blood lipid profile
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
Change in blood pressure
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
Change in body mass index (BMI)
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
Change in grip strength
From baseline, to 1 week post-surgery and 7 weeks post-surgery.
- +2 more secondary outcomes
Study Arms (2)
Exercise
EXPERIMENTALPatients in the Exercise group will follow a fully-supervised exercise routine (Reduced-exertion, high-intensity interval training (REHIT)) with 3 weekly 10-minute training sessions consisting of easy cycling interspersed with 2 brief 'all-out' cycle sprints. Patients in this group will also be offered up to 6 sessions of cognitive behavioral therapy. The duration of the intervention will be the weeks between enrolling in the study and surgery (\~1-4 weeks), as well as an additional period of up to 6 weeks following surgery.
Standard care
NO INTERVENTIONPatients allocated to the Standard Care group will receive the care they would have also received if they would not have participated in the study. They will however undergo the same testing sessions as patients in the Exercise group.
Interventions
As in arm/group description
Up to six 30/40-minute sessions of face-to-face psychotherapy will be offered based on a cognitive model of adjustment to cancer utilizing cognitive and behavioral therapy techniques as described by Moorey \& Greer (2012)
Eligibility Criteria
You may qualify if:
- Recent diagnosis of biopsy-proven primary invasive breast cancer
- Pre- or post-menopausal women
- World Health Organisation Performance status 0-2
- No distant metastasis
- On a treatment plan of:
- surgery (breast conservation surgery or mastectomy with or without reconstruction, including axillary surgery)
- Adjuvant treatment with hormonal therapy and/or radiotherapy
- Adjuvant chemotherapy with or without anti-Her-2 therapy
- Can start the study within 1 week of diagnosis and prior to surgery
- Have surgery arranged within 1-4 weeks of diagnosis
- All receptor statuses are eligible
You may not qualify if:
- BMI \> 35 kg·m-2
- Age \< 35 y or \> 60 y
- Men
- Verbal self-report of undertaking five or more structured exercise sessions per week, perceived as being moderate-to-vigorous intensity, and each session being ≥ 30 minutes in duration
- Contraindications to exercise as determined using the Physical Activity Readiness Questionnaire (PAR-Q)
- Any known significant cardiovascular (except controlled hypertension), pulmonary (except treated/controlled asthma) or metabolic disease (except hypercholesterolemia or type II diabetes)
- Auto-immune disease or exercise-limiting inflammatory arthritis
- Distant metastasis
- Secondary breast cancer or previous diagnosis of invasive cancer and treatment within last 5 years except
- Localised basal cell carcinoma or squamous cell carcinoma of skin
- In situ melanoma
- Cervical intraepithelial neoplasia (CIN)
- Neoadjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Stirlinglead
- University of Bathcollaborator
- Oxford Brookes Universitycollaborator
Study Sites (1)
Manor Hospital
Oxford, OX3 7RP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niels BJ Vollaard, PhD
University of Stirling
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 6, 2017
Study Start
May 1, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
This is a small study which will generate pilot data for larger trials. Although the investigators will publish group data there is no plan to share individual data with other researchers. However, any requests for anonymised individual data will be considered on a case-by-case basis.