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Trial registered on ANZCTR


Registration number
ACTRN12616000318482
Ethics application status
Approved
Date submitted
2/03/2016
Date registered
10/03/2016
Date last updated
21/02/2019
Date data sharing statement initially provided
21/02/2019
Date results information initially provided
21/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of balance and exercise training on chemotherapy-induced peripheral neuropathy
Scientific title
Chemotherapy-induced peripheral neuropathy: effect of exercise and balance training
Secondary ID [1] 288654 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced peripheral neuropathy 297840 0
Condition category
Condition code
Neurological 298014 298014 0 0
Other neurological disorders
Cancer 298015 298015 0 0
Any cancer
Physical Medicine / Rehabilitation 298062 298062 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following an 8-week waiting period, participants will undergo an 8-week exercise and balance training intervention consisting of three weekly 45-60 minute exercise sessions. For the first 4 weeks of the intervention, 2 weekly sessions will be conducted under 1 on 1 supervision by Accredited Exercise Physiologists, with 1 weekly session conducted at a time and place of the participant’s choosing. The final 4 weeks will consist of 1 supervised and 2 unsupervised weekly exercise sessions. Exercise intensity will be individually suited to each participant and progressively increased over the course of the intervention. Each exercise session will consist of approximately 10-20 minutes of cardiovascular exercise (cycle ergometer or treadmill), 20 minutes of strength training (leg press, squat, step-ups, and targeted lower leg exercises using weight machines, dumbbells, or therabands for resistance), and 15-20 minutes of balance training exercise (walking with narrow base of support and single leg standing on stable and labile surfaces, with and without visual feedback). Adherence will be monitored through an attendance log for supervised sessions and a self-report participant exercise diary for unsupervised sessions.
Intervention code [1] 294070 0
Treatment: Other
Comparator / control treatment
The control treatment of this single-group study is the 8-week waiting period completed without a formal exercise program prior to the 8-week exercise intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297549 0
Functional gait, assessed using 6-minute walk test (6MWT)
Timepoint [1] 297549 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [1] 321377 0
Functional balance, assessed using 5-times sit-to-stand
Timepoint [1] 321377 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [2] 321378 0
Postural sway, assessed using force plate
Timepoint [2] 321378 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [3] 321379 0
EORTC-CIPN20 (quality of life questionnaire)
Timepoint [3] 321379 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [4] 321380 0
SF-36 (quality of life questionnaire)
Timepoint [4] 321380 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [5] 321381 0
CIPN-R-ODS (quality of life questionnaire)
Timepoint [5] 321381 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [6] 321382 0
Total Neuropathy Score (includes assessment of both sensory and motor neuropathy)
Timepoint [6] 321382 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [7] 321383 0
Fine motor function, assessed using the pegboard test
Timepoint [7] 321383 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [8] 321384 0
Physical activity monitoring (using Actical)
Timepoint [8] 321384 0
Baseline, mid-point (8 weeks), final (16 weeks)
Secondary outcome [9] 321385 0
Neurophysiological parameters, assessed by nerve conduction studies
Timepoint [9] 321385 0
Baseline, mid-point (8 weeks), final (16 weeks)

Eligibility
Key inclusion criteria
1. Grade 2 or 3 chemotherapy-induced peripheral neuropathy
2. At least 3 months post-chemotherapy treatment
3. Previously treated with chemotherapy for which neuropathy is a known side effect
4. Greater than 18 years of age
5. Able to provide written informed consent
6. Cleared by a physician to participate in a supervised exercise program
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal impairment preventing participation (e.g. inability to walk independently)

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)
N/A (single group study)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A (single group study)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single group cohort design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analysis will be a comparison between baseline, 8 week, and 16 week time-points on the investigated outcomes using a repeated measures ANOVA. A priori covariates including chemotherapy dose, chemotherapy drug, and time from cessation of treatment to baseline time-point will be included in the analysis. Changes in functional (gait & balance), neurophysiologic, and quality of life outcomes will be compared across the three time-points of the study to assess effects of the 8-week exercise intervention vs. the naturally occurring adaptive improvements of the 8-week inactive control period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5366 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 13217 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 25774 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 293024 0
Government body
Name [1] 293024 0
Cancer Institute NSW
Address [1] 293024 0
PO Box 41
Alexandria, NSW 1435
Country [1] 293024 0
Australia
Primary sponsor type
Government body
Name
Cancer Institute NSW
Address
PO Box 41
Alexandria, NSW 1435
Country
Australia
Secondary sponsor category [1] 291800 0
None
Name [1] 291800 0
Address [1] 291800 0
Country [1] 291800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294535 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294535 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick, NSW 2013
Ethics committee country [1] 294535 0
Australia
Date submitted for ethics approval [1] 294535 0
20/11/2015
Approval date [1] 294535 0
26/02/2016
Ethics approval number [1] 294535 0
15/318

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy of an exercise and balance training intervention in patients with chemotherapy-induced peripheral neuropathy (CIPN) on functional, neurophysiological, and quality of life outcomes.

Who is it for?
Cancer survivors at least 3 months-post treatment, aged 18 or over, and with grade 2 or 3 CIPN.

Study details
All participants in this study will first complete an 8 week wait period to assess the rate of adaptive improvements occurring 'naturally' (e.g. without an exercise intervention). Participants will then complete an 8 week exercise program involving a combination of supervised and unsupervised exercise sessions, totaling three 45-60 minutes sessions per week. Sessions will include a combination of cardiovascular training, strength training and balance training. Participants will be asked to complete a number of assessments and questionnaires at enrolment, after the 8 week wait period and again after the 8 week exercise program. Assessments will include physical function tests, nerve testing, and quality of life questionnaires. This pilot study is being conducted to provide insight regarding the efficacy of exercise and balance training for the treatment of CIPN.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64002 0
Prof David Goldstein
Address 64002 0
Department of Medical Oncology
Prince of Wales Hospital
High Street
Randwick, NSW 2031
Country 64002 0
Australia
Phone 64002 0
+61 2 9382 2600
Fax 64002 0
Email 64002 0
d.goldstein@unsw.edu.au
Contact person for public queries
Name 64003 0
Mr J. Matt McCrary
Address 64003 0
Lowy Cancer Research Centre, Level 4
UNSW Australia
Sydney, NSW 2052
Country 64003 0
Australia
Phone 64003 0
+61 2 9385 2971
Fax 64003 0
Email 64003 0
j.mccrary@unsw.edu.au
Contact person for scientific queries
Name 64004 0
Mr J. Matt McCrary
Address 64004 0
Lowy Cancer Research Centre, Level 4
UNSW Australia
Sydney, NSW 2052
Country 64004 0
Australia
Phone 64004 0
+61 2 9385 2971
Fax 64004 0
Email 64004 0
j.mccrary@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1427 0
McCrary JM, Goldstein D, Sandler CX, Barry BK, Marthick M, Timmins HC, Li T, Horvath L, Grimison P, Park SB. (2019) Exercise-based rehabilitation for cancer survivors with chemotherapy-induced peripheral neuropathy. Supportive Care in Cancer https://doi.org/10.1007/s00520-019-04680-w
Attachments [1] 1427 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary