Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 3:03 AM
Study NCT ID:
NCT05531695
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Study in Brain and CNS Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D018583', 'term': 'Pliability'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity and exercise readiness questionnaire; physical activity readiness questionnaire (PARQ)', 'timeFrame': 'one week', 'description': 'Exercise readiness and behaviour to be assessed by administering the physical activity readiness questionnaire (PARQ). These are self-report paper based questionnaires which will be administered at baseline only. (Scale of 0-7).'}, {'measure': 'Physical activity and exercise readiness questionnaire: Godin leisure time exercise questionnaire', 'timeFrame': 'One Week', 'description': 'Exercise readiness and behaviour to be assessed by administering the Godin leisure time exercise questionnaire. These are self-report paper based questionnaires which will be administered at baseline only. (Scale 0-99)'}], 'primaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': '4 weeks', 'description': 'Hand grip strength in Kg of study participants using portable dynamometry before and after intervention.'}, {'measure': '6 minute walk test.', 'timeFrame': '4 weeks', 'description': 'Distance walked in metres by participants in 6 minutes on a level indoor surface before and after intervention.'}, {'measure': 'Sit and reach test', 'timeFrame': '4 weeks', 'description': 'Flexibility measurement in centimetres using a sit and reach box'}, {'measure': 'Vertical jump test', 'timeFrame': '4 weeks', 'description': 'Vertical height jumped in centimetres using an electronic jump mat'}, {'measure': 'Karnofsky Performance Status (KPS)', 'timeFrame': '4 weeks', 'description': 'Measurement or performace on an ordinal rating scale'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life (HRQOL) of participants before and after intervention: questionnaires', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'C-reactive protein level', 'timeFrame': '4 weeks', 'description': 'C-reactive protein (CRP) in blood samples collected from participants before and after the exercise intervention.'}, {'measure': 'Full Blood Count', 'timeFrame': '4 weeks', 'description': 'Full blood count (FBC) as measure of disease burden and inflammatory response'}, {'measure': 'Interleukin-6 assay', 'timeFrame': '4 weeks', 'description': 'Interleukin 6 (IL6) in pre and post intervention samples'}, {'measure': 'Plasma viscosity (PV)', 'timeFrame': '4 weeks', 'description': 'Plasma viscosity (PV) as a measure of hydration response to exercise intervention.'}, {'measure': 'Insulin-like growth factor 1 (IGF1)', 'timeFrame': '4 weeks', 'description': 'Plasma assay of insulin-like growth factor 1 (IGF1) to evaluate metabolic response to intervention.'}, {'measure': 'Insulkin-like Growth Factor Binding Protein -3 (IGFBP3)', 'timeFrame': '4 weeks', 'description': 'Serum level of insulin-like growth factor binding protein (IGFBP3) to evaluate the metabolic response to exercise intervention.'}, {'measure': 'Serum Uric acid', 'timeFrame': '4 weeks', 'description': 'Serum Uric acid level as a measure of hydration response to exercise intervention will be assessed.'}, {'measure': 'Borg rate of perceived exercition', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Functional independence measure (FIM) and Functional assessment measure (FAM)', 'timeFrame': '4 weeks', 'description': 'Measure of functional indepence in performance activities of daily living'}, {'measure': 'Rehabilitation Complexity scale (RCS).', 'timeFrame': '4 weeks', 'description': 'Measure of clinical complexity derived from aggegate score of subscales of therapeutic interventions (scored from 0-15)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer of Brain and Nervous System']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "Study design:\n\nRandomised 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.\n\nParticipants 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.\n\nResearch setting:\n\nThe 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.\n\nDemographic information:\n\nParticipants' 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.\n\nAssessments\n\nThere 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:\n\n1. 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.\n2. 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.\n3. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (aged 18 years plus).\n* Diagnosis of a primary brain and CNS cancer.\n* 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.\n* 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).\n* Able to provide consent.\n\nExclusion Criteria:\n\n* Severe ataxia.\n* Co-morbidities such as severe cardiovascular or respiratory disease.\n* Acute or emergency neurosurgical intervention as primary treatment (the pre-operative exercise phase cannot be implemented).\n* Uncontrolled seizure disorder.\n* Patients primarily for palliation or on end of life care pathway.\n* Patients who require barrier nursing for infection control.'}, 'identificationModule': {'nctId': 'NCT05531695', 'acronym': 'ESIBAC', 'briefTitle': 'Exercise Study in Brain and CNS Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Pilot Study of Moderate Intensity Exercise as Adjuvant Therapy in the Management of Brain and Central Nervous System Cancer', 'orgStudyIdInfo': {'id': 'R1789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'Graduated supervised moderate intensity aerobic exercise', 'interventionNames': ['Behavioral: Exercise (either aerobic or flexibility)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flexibility Exercise', 'description': 'Home based self-supervised flexibility exercises', 'interventionNames': ['Behavioral: Exercise (either aerobic or flexibility)']}], 'interventions': [{'name': 'Exercise (either aerobic or flexibility)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Aerobic Exercise', 'Flexibility Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'overallOfficials': [{'name': 'James E Turner, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bath'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Bath', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}