Cancer of Brain and Nervous SystemESIBACNCT05531695
Exercise Study in Brain and CNS Cancer
A study testing Exercise (either aerobic or flexibility) in people with Cancer of Brain and Nervous System, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Brain and Nervous System
- What is being tested?
- Exercise (either aerobic or flexibility)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (aged 18 years plus).
- Diagnosis of a primary brain and CNS cancer.
- Patients with recurrent brain/CNS tumours eligible for further excision surgery will be included. This is because this group of patients are considered to have good performance score and similar in many characteristics to newly diagnosed patients with brain tumour.
- No contraindication to undertaking moderate aerobic physical activity such as unstable angina, acute systemic illness or fever, uncontrolled diabetes, recent embolism (< 4 weeks), resting heart rate > 120 beats per minute, severe uncontrolled hypertension (180/110 mmHg), progressing worsening dyspnoea at rest or exertion over previous 3-5 days and severe anaemia (haemoglobin concentration ≤ 60 g/L).
- Able to provide consent.
Who cannot join
- Severe ataxia.
- Co-morbidities such as severe cardiovascular or respiratory disease.
- Acute or emergency neurosurgical intervention as primary treatment (the pre-operative exercise phase cannot be implemented).
- Uncontrolled seizure disorder.
- Patients primarily for palliation or on end of life care pathway.
- Patients who require barrier nursing for infection control.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Hull, East Yorkshire, HU16 5JQ
About this study
Official title: A Pilot Study of Moderate Intensity Exercise as Adjuvant Therapy in the Management of Brain and Central Nervous System Cancer
With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Performance status (a quantification tool used in patients with cancer to assess their quality of life and ability to carry out activities of daily living) is a key prognostic factor in Brain and CNS cancers and a good performance status is used in determining whether a patient is offered adjuvant treatment with chemotherapy and radiotherapy following primary surgical treatment. The performance status of a patient is defined by physical and cognitive functioning, and the beneficial effect of aerobic exercise in improving physical functioning (e.g., cardiorespiratory fitness) is well established. Thus, it is anticipated that implementing a supervised moderate intensity aerobic exercise training programme will improve the performance status of patients. An implication of this work is that, exercise regimens could be offered as additional treatment, alongside chemotherapy and radiotherapy, which might increase the chance of survival.
The project design is a randomised controlled trial with two arms in which one group of patients will undergo an aerobic exercise program starting one week before surgery and continuing for three weeks in the post-operative period. Patients enrolled in this trial will continue with standard treatment including neuro-rehabilitation. The control group of patients will be given written instructions on performing flexibility and stretching exercises in addition to their usual care (including neuro-rehabilitation). The primary outcome is performance status as defined by measurements of physical functioning and cognitive ability (e.g., memory, attention, information processing speed). Physical functioning will be assessed by a timed walking test, hand-grip dynamometry and a maximum jump height test. Other measures of well-being will be assessed; including heath related quality of life using the European Quality of Life-5 Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy- Brain (FACT-Br) questionnaires. Secondary outcome measures will be measurements of mood, fatigue and certain biochemical parameters, such as C-reactive protein (CRP), plasma viscosity (PV), full blood count (FBC), uric acid, insulin-like growth factor 1 (IGF-1), and insulin-like growth factor binding protein 3 (IGFBP-3). It is anticipated that a total of 30 patients will be recruited split between the two groups and each participant will not spend more than four weeks in taking part in the study.
Read the detailed description
Study design:
Randomised controlled trial. Participants will be randomised into one of two groups: intervention or control. Participants in the intervention group will undergo a supervised moderate intensity aerobic exercise programme in addition to routine treatment starting 1 week after their primary treatment (surgery/radiotherapy) for 3 weeks.
Participants in the control group will undergo a programme involving muscle stretching (flexibility) exercises using a combination of active and passive static stretching to target the major muscle tendon units of the neck, shoulder girdle, chest, trunk, lower back, hips, legs (posterior and anterior aspects) and ankles over the same time period as the intervention group. The exercises in this group will be unsupervised. Patients will be provided with written clear instructions listing the stretches to perform. These written instructions will be supplemented with diagrams for each stretch manoeuvre.
Research setting:
The project will be based within the premises of the Hull and East Yorkshire hospital NHS Trust. This is an acute care tertiary centre based over two hospital sites: the Hull Royal Infirmary (HRI) and Castle Hill Hospital (CHH). The neurosurgical ward and operating theatres are based at the HRI site while the inpatient specialist rehabilitation ward and the oncology facilities and clinicians are based at the Queens Centre for Oncology/Haematology within the premises of CHH. The neurosurgery outpatient clinic is also based at CHH site. The facilities and equipment for the exercise intervention will be based in a dedicated specialist inpatient rehabilitation unit on ward 29 at the Queens centre. The Queens Centre is a purpose built oncological facility that co-locates all of the services (including psychology) involved in cancer care apart from surgical services. This protocol and proposal has been utilised in making ethics submission across 2 institutions- the University of Bath and the Hull and East Yorkshire Hospital NHS Trust hosting the study setting.
Demographic information:
Participants' medical history will be obtained from the hospital records. Medical co-morbidities may affect clinical outcome in patients with brain and CNS cancers. However, collected information will be anonymised and patient identification information will remain within the clinical setting. These will be stored under data protection regulations that govern the NHS.
Assessments
There are 3 designated time points in the course of the study during which the assessment tools for the outcome measures will be administered. These are:
- Baseline. This marks the entry period into the study when informed written consent has been obtained. It is designed to coincide with the first visit to the project base prior to commencing the exercise programme. Fast-track access to neuro-oncology multidisciplinary team assessment clinic within 1-2 weeks of referral is the norm. The nature of this clinical diagnosis is such that surgical intervention in eligible patients is scheduled within 2 weeks of clinic appointment hence the time constraints of the pre-operative phase.
- The first post-operative assessment. This is scheduled to take place one week after operation in order to allow for tissue healing and post-operative inflammatory processes to settle. It is acknowledged that the post-operative medical stability cannot be predicted and the assessment scheduled for this period may be delayed to such a time when the patient is assessed to be medically stable enough to resume the rehabilitation program. All of this information will be recorded.
- The final assessment. This will be undertaken following completion of the 3 week exercise programme in the post-operative period. This will also mark the official termination point of the patient intervention part of the study.
- Conditions
- Cancer of Brain and Nervous System
- Being tested
- Exercise (either aerobic or flexibility)
- Medical subject headings
- Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise (either aerobic or flexibility)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Graduated supervised moderate intensity aerobic exercise Receives: Behavioral: Exercise (either aerobic or flexibility) |
| Flexibility Exercise | Active comparator | Home based self-supervised flexibility exercises Receives: Behavioral: Exercise (either aerobic or flexibility) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength in Kg of study participants using portable dynamometry before and after intervention.
Measured: 4 weeks
6 minute walk test.
Distance walked in metres by participants in 6 minutes on a level indoor surface before and after intervention.
Measured: 4 weeks
Sit and reach test
Flexibility measurement in centimetres using a sit and reach box
Measured: 4 weeks
Vertical jump test
Vertical height jumped in centimetres using an electronic jump mat
Measured: 4 weeks
Karnofsky Performance Status (KPS)
Measurement or performace on an ordinal rating scale
Measured: 4 weeks
Secondary outcomes (11)
Health related quality of life (HRQOL) of participants before and after intervention: questionnaires
The HRQOL of patients with primary brain and CNS tumour following primary treatment as measured by the following self-report paper-based questionnaires: These questionnaires will be administered at the three assessment points.
Measured: 4 weeks
C-reactive protein level
C-reactive protein (CRP) in blood samples collected from participants before and after the exercise intervention.
Measured: 4 weeks
Full Blood Count
Full blood count (FBC) as measure of disease burden and inflammatory response
Measured: 4 weeks
Interleukin-6 assay
Interleukin 6 (IL6) in pre and post intervention samples
Measured: 4 weeks
Plasma viscosity (PV)
Plasma viscosity (PV) as a measure of hydration response to exercise intervention.
Measured: 4 weeks
Insulin-like growth factor 1 (IGF1)
Plasma assay of insulin-like growth factor 1 (IGF1) to evaluate metabolic response to intervention.
Measured: 4 weeks
Insulkin-like Growth Factor Binding Protein -3 (IGFBP3)
Serum level of insulin-like growth factor binding protein (IGFBP3) to evaluate the metabolic response to exercise intervention.
Measured: 4 weeks
Serum Uric acid
Serum Uric acid level as a measure of hydration response to exercise intervention will be assessed.
Measured: 4 weeks
Borg rate of perceived exercition
An assessment of individual participants perception of the degree of exertion in relation to their assigned exercise programme using the Borg rating scale of perceived exertion.
Measured: 4 weeks
Functional independence measure (FIM) and Functional assessment measure (FAM)
Measure of functional indepence in performance activities of daily living
Measured: 4 weeks
Rehabilitation Complexity scale (RCS).
Measure of clinical complexity derived from aggegate score of subscales of therapeutic interventions (scored from 0-15)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study startNov 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Brain and Nervous SystemStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Bath
- Responsible party
- Sponsor
- Investigators
- James E Turner, PhD, Study chair, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531695
- Sponsor's protocol ID
- R1789
- Acronym
- ESIBAC
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Moderate Intensity Exercise as Adjuvant Therapy in the Management of Brain and Central Nervous System Cancer
- ClinicalTrials.gov ID
- NCT05531695
- Acronym / sponsor ID
- ESIBAC / R1789
- Conditions
- Cancer of Brain and Nervous System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Bath
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Sep 2022 (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.
With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Performance status (a quantification tool used in patients with cancer to assess their quality of life and ability to carry out activities of daily living) is a key prognostic factor in Brain and CNS cancers and a good performance status is used in determining whether a patient is offered adjuvant treatment with chemotherapy and radiotherapy following primary surgical treatment. The performance status of a patient is defined by physical and cognitive functioning, and the beneficial effect of aerobic exercise in improving physical functioning (e.g., cardiorespiratory fitness) is well established. Thus, it is anticipated that implementing a supervised moderate intensity aerobic exercise training programme will improve the performance status of patients. An implication of this work is that, exercise regimens could be offered as additional treatment, alongside chemotherapy and radiotherapy, which might increase the chance of survival.
The project design is a randomised controlled trial with two arms in which one group of patients will undergo an aerobic exercise program starting one week before surgery and continuing for three weeks in the post-operative period. Patients enrolled in this trial will continue with standard treatment including neuro-rehabilitation. The control group of patients will be given written instructions on performing flexibility and stretching exercises in addition to their usual care (including neuro-rehabilitation). The primary outcome is performance status as defined by measurements of physical functioning and cognitive ability (e.g., memory, attention, information processing speed). Physical functioning will be assessed by a timed walking test, hand-grip dynamometry and a maximum jump height test. Other measures of well-being will be assessed; including heath related quality of life using the European Quality of Life-5 Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy- Brain (FACT-Br) questionnaires. Secondary outcome measures will be measurements of mood, fatigue and certain biochemical parameters, such as C-reactive protein (CRP), plasma viscosity (PV), full blood count (FBC), uric acid, insulin-like growth factor 1 (IGF-1), and insulin-like growth factor binding protein 3 (IGFBP-3). It is anticipated that a total of 30 patients will be recruited split between the two groups and each participant will not spend more than four weeks in taking part in the study.
Detailed description
Study design:
Randomised controlled trial. Participants will be randomised into one of two groups: intervention or control. Participants in the intervention group will undergo a supervised moderate intensity aerobic exercise programme in addition to routine treatment starting 1 week after their primary treatment (surgery/radiotherapy) for 3 weeks.
Participants in the control group will undergo a programme involving muscle stretching (flexibility) exercises using a combination of active and passive static stretching to target the major muscle tendon units of the neck, shoulder girdle, chest, trunk, lower back, hips, legs (posterior and anterior aspects) and ankles over the same time period as the intervention group. The exercises in this group will be unsupervised. Patients will be provided with written clear instructions listing the stretches to perform. These written instructions will be supplemented with diagrams for each stretch manoeuvre.
Research setting:
The project will be based within the premises of the Hull and East Yorkshire hospital NHS Trust. This is an acute care tertiary centre based over two hospital sites: the Hull Royal Infirmary (HRI) and Castle Hill Hospital (CHH). The neurosurgical ward and operating theatres are based at the HRI site while the inpatient specialist rehabilitation ward and the oncology facilities and clinicians are based at the Queens Centre for Oncology/Haematology within the premises of CHH. The neurosurgery outpatient clinic is also based at CHH site. The facilities and equipment for the exercise intervention will be based in a dedicated specialist inpatient rehabilitation unit on ward 29 at the Queens centre. The Queens Centre is a purpose built oncological facility that co-locates all of the services (including psychology) involved in cancer care apart from surgical services. This protocol and proposal has been utilised in making ethics submission across 2 institutions- the University of Bath and the Hull and East Yorkshire Hospital NHS Trust hosting the study setting.
Demographic information:
Participants' medical history will be obtained from the hospital records. Medical co-morbidities may affect clinical outcome in patients with brain and CNS cancers. However, collected information will be anonymised and patient identification information will remain within the clinical setting. These will be stored under data protection regulations that govern the NHS.
Assessments
There are 3 designated time points in the course of the study during which the assessment tools for the outcome measures will be administered. These are:
- Baseline. This marks the entry period into the study when informed written consent has been obtained. It is designed to coincide with the first visit to the project base prior to commencing the exercise programme. Fast-track access to neuro-oncology multidisciplinary team assessment clinic within 1-2 weeks of referral is the norm. The nature of this clinical diagnosis is such that surgical intervention in eligible patients is scheduled within 2 weeks of clinic appointment hence the time constraints of the pre-operative phase.
- The first post-operative assessment. This is scheduled to take place one week after operation in order to allow for tissue healing and post-operative inflammatory processes to settle. It is acknowledged that the post-operative medical stability cannot be predicted and the assessment scheduled for this period may be delayed to such a time when the patient is assessed to be medically stable enough to resume the rehabilitation program. All of this information will be recorded.
- The final assessment. This will be undertaken following completion of the 3 week exercise programme in the post-operative period. This will also mark the official termination point of the patient intervention part of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Exercise (either aerobic or flexibility)Graduated supervised moderate intensity aerobic exercise |
| Flexibility Exercise | Active comparator | Behavioral: Exercise (either aerobic or flexibility)Home based self-supervised flexibility exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (aged 18 years plus).
- Diagnosis of a primary brain and CNS cancer.
- Patients with recurrent brain/CNS tumours eligible for further excision surgery will be included. This is because this group of patients are considered to have good performance score and similar in many characteristics to newly diagnosed patients with brain tumour.
- No contraindication to undertaking moderate aerobic physical activity such as unstable angina, acute systemic illness or fever, uncontrolled diabetes, recent embolism (< 4 weeks), resting heart rate > 120 beats per minute, severe uncontrolled hypertension (180/110 mmHg), progressing worsening dyspnoea at rest or exertion over previous 3-5 days and severe anaemia (haemoglobin concentration ≤ 60 g/L).
- Able to provide consent.
Key exclusion criteria (6 listed)
- Severe ataxia.
- Co-morbidities such as severe cardiovascular or respiratory disease.
- Acute or emergency neurosurgical intervention as primary treatment (the pre-operative exercise phase cannot be implemented).
- Uncontrolled seizure disorder.
- Patients primarily for palliation or on end of life care pathway.
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 (either aerobic or flexibility) | Behavioural | Aerobic Exercise, Flexibility Exercise |
Primary outcome
Hand grip strength
Time frame: 4 weeks
Hand grip strength in Kg of study participants using portable dynamometry before and after intervention.
6 minute walk test.
Time frame: 4 weeks
Distance walked in metres by participants in 6 minutes on a level indoor surface before and after intervention.
Sit and reach test
Time frame: 4 weeks
Flexibility measurement in centimetres using a sit and reach box
Vertical jump test
Time frame: 4 weeks
Vertical height jumped in centimetres using an electronic jump mat
Karnofsky Performance Status (KPS)
Time frame: 4 weeks
Measurement or performace on an ordinal rating scale
11 secondary outcomes
Health related quality of life (HRQOL) of participants before and after intervention: questionnaires
Time frame: 4 weeks
C-reactive protein level
Time frame: 4 weeks
Full Blood Count
Time frame: 4 weeks
Interleukin-6 assay
Time frame: 4 weeks
Plasma viscosity (PV)
Time frame: 4 weeks
Insulin-like growth factor 1 (IGF1)
Time frame: 4 weeks
Insulkin-like Growth Factor Binding Protein -3 (IGFBP3)
Time frame: 4 weeks
Serum Uric acid
Time frame: 4 weeks
Borg rate of perceived exercition
Time frame: 4 weeks
Functional independence measure (FIM) and Functional assessment measure (FAM)
Time frame: 4 weeks
Rehabilitation Complexity scale (RCS).
Time frame: 4 weeks
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 8 Sep 2022.
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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.
James E Turner, PhD study chair
University of Bath
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 (either aerobic or flexibility) in people with Cancer of Brain and Nervous System, run by Hull University Teaching Hospitals NHS Trust 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 6 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 8 Sep 2022. 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?
Hand grip strength (time frame: 4 weeks). The study lists 5 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 8 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.