Exercise Study in Brain and CNS Cancer

NCT05531695 | Completed DMC

• 1 other identifier: R1789
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer of Brain and Nervous System

Outcome Measures

Primary Outcomes (5)

• Hand grip strength

  Hand grip strength in Kg of study participants using portable dynamometry before and after intervention.

  4 weeks

• 6 minute walk test.

  Distance walked in metres by participants in 6 minutes on a level indoor surface before and after intervention.

  4 weeks

• Sit and reach test

  Flexibility measurement in centimetres using a sit and reach box

  4 weeks

• Vertical jump test

  Vertical height jumped in centimetres using an electronic jump mat

  4 weeks

• Karnofsky Performance Status (KPS)

  Measurement or performace on an ordinal rating scale

  4 weeks

Secondary Outcomes (11)

• Health related quality of life (HRQOL) of participants before and after intervention: questionnaires

  4 weeks

• C-reactive protein level

  4 weeks

• Full Blood Count

  4 weeks

• Interleukin-6 assay

  4 weeks

• Plasma viscosity (PV)

  4 weeks

Other Outcomes (2)

• Physical activity and exercise readiness questionnaire; physical activity readiness questionnaire (PARQ)

  one week

• Physical activity and exercise readiness questionnaire: Godin leisure time exercise questionnaire

  One Week

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Graduated supervised moderate intensity aerobic exercise

Behavioral: Exercise (either aerobic or flexibility)

Flexibility Exercise

ACTIVE COMPARATOR

Home based self-supervised flexibility exercises

Behavioral: Exercise (either aerobic or flexibility)

Interventions

Exercise (either aerobic or flexibility) BEHAVIORAL

Aerobic Exercise; Flexibility Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Bath: collaborator

Study Sites (1)

Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Brain Neoplasms; Neurologic Manifestations

Interventions

Exercise; Pliability

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mechanical Phenomena; Physical Phenomena

Study Officials

• James E Turner, PhD

  University of Bath

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: September 8, 2022
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

GB (1)