Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000677808
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
3/06/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intra-infusion exercise on chemotherapy side effects
Scientific title
The effect of intra-infusion exercise on chemotherapy side effects in patients with breast, colorectal or ovarian cancer
Secondary ID [1] 303885 0
None
Universal Trial Number (UTN)
Trial acronym
EX-FUSION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 321462 0
Colorectal cancer 321829 0
Ovarian cancer 333442 0
Condition category
Condition code
Cancer 319223 319223 0 0
Breast
Cancer 319560 319560 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 330117 330117 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise intervention will be delivered for 3 sessions in a one-on-one setting with an accredited exercise physiologist when patients have their scheduled chemotherapy infusion. The duration of the study will depend on the frequency of chemotherapy infusions which is variable between individuals.
Exercise will involve the participant cycling on a stationary foot bike whilst seated in their usual chemotherapy chair for 20 minutes continuously at a moderate intensity (40-50% heart rate reserve and a rate of perceived exertion 12-14). Pre-task will commence after 10 minutes of chemotherapy infusion to confirm the absence of adverse reactions to the infusion. Physiological measures will be recorded during pre-task (10 minutes), task (exercise, 20 minutes) and recovery (20 minutes). These measures include heart rate, blood pressure and oxygen saturation. Rating of perceived exertion using the Borg RPE scale will also be measured during the task. Adherence will be monitored by session attendance checklists.
During the recovery period, the exercise group will be provided with exercise education by an accredited exercise physiologist. The initial exercise education session will involve the accredited exercise physiologist discussing goal setting, barriers to exercise, current exercise knowledge and exercise history. The accredited exercise physiologist will use an education booklet in subsequent sessions to address strategies to overcome exercise barriers. The “Exercise for People Living with Cancer; A guide for people with cancer, their families and friends” booklet by the Cancer Council will be used as a supplementary booklet for participants who would like more information about resistance exercise.
Intervention code [1] 320195 0
Treatment: Other
Comparator / control treatment
The control group will continue with routine clinical care but will also receive exercise education. Routine clinical care involves patients receiving chemotherapy infusion without exercise. The exercise education provided will be the same as the intervention group but will occur during the 60 minute infusion period.
Control group
Active

Outcomes
Primary outcome [1] 327099 0
Fatigue using the FACIT-Fatigue questionnaire
Timepoint [1] 327099 0
FACIT-Fatigue questionnaire will be used at the beginning and the end of the study (1 week after intervention session 3).
Primary outcome [2] 327420 0
Daily symptom diary which includes 2 questionnaires: the Edmonton Symptom Assessment System and the Brief Fatigue Inventory.
Timepoint [2] 327420 0
The daily symptom diary will be used for 7 days after each intervention session starting on the day after chemotherapy infusion. .
Secondary outcome [1] 393783 0
Chemotherapy side effects using a daily symptom diary which includes the Edmonton Symptom Assessment System and the Brief Fatigue Inventory.
Timepoint [1] 393783 0
The daily symptom diary will be used for 7 days after each intervention session starting on the day after chemotherapy infusion.
Secondary outcome [2] 393791 0
Quality of life using EORTC QLQ-C30 questionnaire
Timepoint [2] 393791 0
At the start and end of the study (1 week after intervention session 3)
Secondary outcome [3] 393792 0
Physical activity behaviour using IPAQ questionnaire
Timepoint [3] 393792 0
The IPAQ questionnaire will be given at the start of the study, at the beginning of each intervention session and 1 week after intervention 3.
Secondary outcome [4] 393793 0
Heart rate response to exercise using a pulse oximeter
Timepoint [4] 393793 0
Continuously for 10 minutes pre-task, 20 minutes during task and 20 minutes in recovery
Secondary outcome [5] 393794 0
Blood pressure response to exercise using a sphygmomanometer
Timepoint [5] 393794 0
Every 5 minutes for 10 minutes pre-task, 20 minutes during task and 20 minutes in recovery
Secondary outcome [6] 393795 0
Oxygen saturation response to exercise using a pulse oximeter
Timepoint [6] 393795 0
Continuously for 10 minutes pre-task, 20 minutes during task and 20 minutes in recovery
Secondary outcome [7] 393796 0
Experience and acceptability (as composite outcomes) of exercise during chemotherapy infusion using exit interview
Timepoint [7] 393796 0
1 week after intervention session 3
Secondary outcome [8] 395089 0
Chemotherapy-induced peripheral neuropathy assessed using FACT/GOG-Ntx
Timepoint [8] 395089 0
The FACT/GOG-Ntx will be given immediately prior to each intervention session.
Secondary outcome [9] 395090 0
Behavioural change using the Stage of Change questionnaire
Timepoint [9] 395090 0
The Stage of Change questionnaire will be given at the beginning of the study
Secondary outcome [10] 395091 0
Self efficacy using Bandura's ESE scale
Timepoint [10] 395091 0
Bandura's ESE scale will be given at the start and 1 week after intervention session 3
Secondary outcome [11] 395092 0
Physical activity and sleep behaviours (as composite secondary outcomes) using Actigraph.
Timepoint [11] 395092 0
The Actigraph will be worn for 7 days following the baseline session and intervention session 3
Secondary outcome [12] 395093 0
Physical activity behaviours using Fitbit
Timepoint [12] 395093 0
The Fitbit will be worn continuously for the duration of the study
Secondary outcome [13] 395094 0
Rate of perceived exertion using the Borg RPE scale
Timepoint [13] 395094 0
RPE will be collected at every 2 minutes during the task at each intervention session

Eligibility
Key inclusion criteria
a. Voluntarily signed the informed consent form
b. Ability to speak and understand English
c. Aged between 18-75 years old
d. Histologically confirmed Stage I-III breast, colorectal or ovarian cancer
e. Current or planned chemotherapy
f. Undergone at least 1 cycle of chemotherapy
g. Plan on receiving at least 4 chemotherapy cycles with duration >60 minutes
h. Treating oncologist approval
i. ECOG 0-2
j. Willingness and ability to comply with all study procedures
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Present with an acute systemic infection or fever
b. Known adverse reaction to infusion
c. Presence of any condition that is contraindicated to exercise
d. Presence of orthopaedic problems, significant peripheral neuropathy or pain that would limit lower body exercise
e. Currently taking beta-blocker medication
f. Currently undergoing immunotherapy
g. Currently receiving anthracycline

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted in a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After the initial baseline session, participants will be randomised to either an intra-infusion exercise group or usual-care control group. Randomisation will occur via a computer-generated randomisation program for group allocation according to subject number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our recent pilot study (Thomas et al., 2019), the only published paper investigating the effects of intra-infusion exercise, has been used to determine sample size for this study. In the pilot study, the effects of intra-infusion exercise on chemotherapy symptoms were assessed using the ESAS-r. Given fatigue is one of the most common and debilitating side effects of chemotherapy, ESAS-r fatigue has been used to calculate sample size in the current study. The effect size (Glass’ Delta) for fatigue was 0.39 in the pilot. With a power of 80% and a significance level of a=0.05 (calculated by G-power), n=36. with an assumed 80% completion rate, in order to obtain full results from 36 participants, a sample size of n=45 is required.

Quantitative data: Descriptive statistics will be used to describe age, height, weight, cancer diagnosis, recruitment and adherence rates. Paired t-tests will be used to compare physical activity levels, quality of life and self-efficacy. Repeated measures ANOVA will be used to analyse heart rate, blood pressure, oxygen saturation, RPE and symptoms. Hypotheses will be tested using a significance level of 0.05 and power of 80%.

Qualitative Data: Each interview will be audio recorded and transcribed verbatim. The qualitative interview transcripts will be coded and themes identified using a framework approach. This approach enables detailed contrasts and exploration of patient factors on their experience. The qualitative approach involves simultaneous data collection and analysis, together with systematic efforts to check and refine developing categories of data. In addition to the research questions formulated at the outset, it is anticipated that others may emerge during the period of data collection.
Methodological rigor will be ensured through creating interviewer memos, transcription review, verbal debriefing, member-checking, multiple and cross-coding and iterative revision of the interview guide.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2022
Actual
19/09/2022
Date of last participant enrolment
Anticipated
30/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
45
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19061 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 33611 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308277 0
Other Collaborative groups
Name [1] 308277 0
Sydney Catalyst
Country [1] 308277 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 309077 0
None
Name [1] 309077 0
Address [1] 309077 0
Country [1] 309077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308252 0
Sydney Local Health District Ethics Review Committee Royal Prince Alfred Hospital Zone
Ethics committee address [1] 308252 0
Ethics committee country [1] 308252 0
Australia
Date submitted for ethics approval [1] 308252 0
24/11/2020
Approval date [1] 308252 0
18/12/2020
Ethics approval number [1] 308252 0
X20-0520 & 2020/ETH03151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110082 0
A/Prof Kate Edwards
Address 110082 0
D18 Susan Wakil Health Building, University of Sydney, Camperdown NSW 2006
Country 110082 0
Australia
Phone 110082 0
+61 2 90367396
Fax 110082 0
Email 110082 0
[email protected]
Contact person for public queries
Name 110083 0
Catherine Seet-Lee
Address 110083 0
D18 Susan Wakil Health Building, University of Sydney, Camperdown NSW 2006
Country 110083 0
Australia
Phone 110083 0
+61 2 93519380
Fax 110083 0
Email 110083 0
[email protected]
Contact person for scientific queries
Name 110084 0
Catherine Seet-Lee
Address 110084 0
D18 Susan Wakil Health Building, University of Sydney, Camperdown NSW 2006
Country 110084 0
Australia
Phone 110084 0
+61 2 93519380
Fax 110084 0
Email 110084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11289Study protocol  [email protected]
11290Informed consent form  [email protected]
11291Ethical approval  [email protected]



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.