Exercise Study in Brain and CNS Cancer

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.