Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000874415
Ethics application status
Approved
Date submitted
4/04/2016
Date registered
5/07/2016
Date last updated
15/06/2022
Date data sharing statement initially provided
31/10/2018
Date results information initially provided
1/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot feasibility study of Exercise in grade III and IV High Grade Glioma (glioblastoma & anaplastic astrocytomas) while undergoing up-front Radiation with or without chemotherapy (EGGR study)
Scientific title
Pilot feasibility study of Exercise in grade III and IV High Grade Glioma (glioblastoma & anaplastic astrocytomas) while undergoing up-front Radiation with or without chemotherapy
Secondary ID [1] 287907 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
EGGR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grade III High Grade Glioma (glioblastoma) 296783 0
Grade III High Grade Glioma (anaplastic astrocytomas) 296784 0
Grade IV High Grade Glioma (glioblastoma) 299061 0
Grade IV High Grade Glioma (anaplastic astrocytomas) 299062 0
Condition category
Condition code
Cancer 297018 297018 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual medical care
Plus
A fourteen-week structured physical activity programme.
- participant will meet a dedicated physiotherapist at the hospital, three times each week (1hr) for seven weeks. After this participant can decide whether to meet face to face or talk over the telephone, weekly, for another seven weeks. (duration of session time depends on participant)
- participants are give a brief diary to fill out and a pedometer (a small device that counts the number of steps you take during the day).
- During the first seven weeks they will take part in a supervised physical activity program at the treating hospital (1hr or shorter if participant is not able to do a full hour). As part of this program they will do some fitness, strength and balance exercises under the supervision of the exercise provider.
These exercises are provided individually but may at some time be performed in a group.
- If participants are not able to do the activities this can be adapted to them, intensity is individualised for each participant

In weeks 8-14 patients receive a one on one supervised exercise session and are expected to perform daily exercise at home (amount of time to what the patient feels comfortable with).

From weeks 14-21 patients are required to perform exercise daily at home independently. (this can be similar exercises to what they have been doing or other forms of exercise they feel comfortable with.

For the physical activity: a) exercise intensity is measured by the RPE borg Scale.
b) exercises are chosen based on the patients level of function. They include a cardio component eg: cycling, walking, treadmill. Strength component and balance.

Intervention is individualised for each patient based on their mobility, strength, co-morbidities and desired outcomes of exercise.
Intervention code [1] 293263 0
Treatment: Other
Comparator / control treatment
Usual medical care
Treated with radiation and sometimes chemotherapy
Control group
Active

Outcomes
Primary outcome [1] 296621 0
The primary objective is to determine the feasibility of delivering the physical activity program and participant assessments

In order to assess the feasibility of i) delivering the intervention and ii) completing study assessment the following information will be recorded for each participant:
- Adherence to physical activity sessions will be measured by recording attendance at these sessions
- Adherence to the planned unsupervised physical activity will be measured via patient diary
- Adherence to study assessments will be assessed via:
- Completion of self-report measures
- Completion of functional performance measures
- Completion of body composition measures
- Accelerometer data will be collected during week 4-6 of the program.
Timepoint [1] 296621 0
14 weeks
Weekly from baseline to 14 weeks after intervention commencement
Primary outcome [2] 298567 0
Quality of life
Quality of life will be assessed using the EORTC-QLQC30. The Cancer Quality of life Questionnaire is a 30-item questionnaire extensively validated in cancer patients. This questionnaire consists of five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain, and nausea/vomiting) and a number of single items assessing additional symptoms.
Timepoint [2] 298567 0
21 weeks
Baseline, Week 7, Week 14, Week 21 after intervention commencement
Primary outcome [3] 298568 0
Functional performance
Functional performance will be assessed via the:
- Six minute Walk Test (6MWT): distance walked by participant in six minutes
- Timed up and go: time taken to rise from seat, walk a specified circuit and return to sitting.
- 30 second chair stand: number of times participant rises to full stand and returns to seated position in 30 seconds.
- Comfortable gait speed: time taken to walk 10 metres.
- One-legged stand tests: time able to stand on one leg.
Timepoint [3] 298568 0
14 weeks
Weekly from baseline to 14 weeks after intervention commencement
Secondary outcome [1] 318943 0
Objective markers of physical fitness
The daily physical activity levels of participants during the intensive phase of the program will be accessed once for one week only (between weeks four to six of the program) by accelerometer. The accelerometer, a small device worn on the participant’s hip and attached to a light belt, will obtain information about the amount of activity performed and will be used as an objective confirmation of activity.
Timepoint [1] 318943 0
Accessed once for one week only. This will be done between weeks four to six.
Secondary outcome [2] 324606 0
Objective markers of body composition (BMI, hip and waist circumference)
Timepoint [2] 324606 0
21 weeks
Baseline, Week 7, Week 14, Week 21 after intervention commencement
Secondary outcome [3] 325315 0
Changes in sleep patterns.
Along with the physical activity levels that will be measured with the accelerometer, we will also collect data regarding participant sleep patterns to provide objective evidence of changes in self-reported sleep outcomes as well as changes in sleep patterns over time.

participants during the intensive phase of the program will be accessed once for one week only (between weeks four to six of the program) by accelerometer. The accelerometer, a small device worn on the participant’s hip and attached to a light belt, will obtain information about the amount of activity performed and will be used as an objective confirmation of activity.
Timepoint [3] 325315 0
Between weeks four and six of the program
Once, for one week

Eligibility
Key inclusion criteria
Newly diagnosed histologically confirmed grade III or IV high grade glioma
Medically fit and recovered from surgical resection
Prior to/at commencement of standard radiotherapy +/- chemotherapy (Temozolomide)
ECOG Performance status of 0-2.
Life expectancy of at least 6 months
Willing and able to comply with all study requirements, including ability to attend and complete exercise program, timing and/or nature of required assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ECOG performance status of 3 and above or Karnofsky performance status of less than 60
Inability to read and understand English
Concurrent illness (including severe infection) or symptoms that may jeopardize the ability of the patient to complete the exercise program outlined in this protocol with reasonable safety
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The cohort study will report descriptive statistics detailing:
- the proportions of participants completing the study intervention
- the proportion of participants completing the study assessments
- Change from baseline across study time points for functional performance, body composition, quality of life, fatigue, sleep, distress, and adverse events.

Data from all participants completing at least the baseline and one other assessment will be included in the analysis.

Regression analysis will be used to explore the impact of disease, treatment and other factors on adherence to the physical activity intervention and study assessment completion.

Results will guide development of future phase II/III studies and will provide objective data on which to estimate magnitude of effects and sample sizes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/01/2015
Date of last participant enrolment
Anticipated
7/11/2019
Actual
4/10/2018
Date of last data collection
Anticipated
Actual
4/03/2019
Sample size
Target
30
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 4658 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 4659 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 4660 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 4661 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 4662 0
Concord Repatriation Hospital - Concord

Funding & Sponsors
Funding source category [1] 292402 0
Hospital
Name [1] 292402 0
Liverpool Hospital
Country [1] 292402 0
Australia
Primary sponsor type
Individual
Name
Dr Eng-Siew Koh
Address
Liverpool Hospital
Elizabeth St & Goulburn St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 291084 0
None
Name [1] 291084 0
Address [1] 291084 0
Country [1] 291084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294749 0
South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 294749 0
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 294749 0
Australia
Date submitted for ethics approval [1] 294749 0
25/08/2014
Approval date [1] 294749 0
07/11/2014
Ethics approval number [1] 294749 0
HREC/14/LPOOL/408

Summary
Brief summary
This pilot study will evaluate the feasibility and safety of a physical activity program in patients who are newly diagnosed with grade III or IV high grade glioma.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with grade III or IV high grade glioma.

Study details
Participants will be allocated to the group depending on participants wishes and abilities , Participants in one group will receive a structured physical activity program plus usual medical care, while the other group will receive usual medical care only. The physical activity program includes 3 x [1hr] supervised sessions per week for 7 weeks followed by once weekly support for weeks 8-14.
All participants will be assessed for suitability to determine which group they should go into. Results from this pilot study will guide development of future studies on physical activity intervention programs in brain cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61454 0
Dr Eng-Siew Koh
Address 61454 0
Liverpool Hospital
Locked Bag 7103 Liverpool BC 1871 NSW
Country 61454 0
Australia
Phone 61454 0
+61 2 8738 9806
Fax 61454 0
+61 2 8738 9819
Email 61454 0
eng-siew.koh@health.nsw.gov.au
Contact person for public queries
Name 61455 0
Mrs Samantha Gillman
Address 61455 0
Liverpool Hospital
Locked Bag 7103, Liverpool BC, NSW 1871
Country 61455 0
Australia
Phone 61455 0
+61 2 8738 9146
Fax 61455 0
+61 2 8738 9205
Email 61455 0
samantha.gillman@health.nsw.gov.au
Contact person for scientific queries
Name 61456 0
Dr Eng-Siew Koh
Address 61456 0
Liverpool Hospital
Locked Bag 7103 Liverpool BC 1871 NSW
Country 61456 0
Australia
Phone 61456 0
+61 2 8738 9806
Fax 61456 0
+61 2 8738 9819
Email 61456 0
eng-siew.koh@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A formulated table will be available but possible not the individual QoL.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.