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Trial registered on ANZCTR


Registration number
ACTRN12620001081909
Ethics application status
Approved
Date submitted
4/08/2020
Date registered
20/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and efficacy of a multi-component exercise program in pancreatic cancer patients receiving preoperative chemotherapy
Scientific title
Exercise medicine as chemotherapy adjunct: the feasibility and efficacy of a multi-component program in pancreatic cancer patients receiving neoadjuvant therapy (The EXPAN Project)
Secondary ID [1] 300690 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 316502 0
Condition category
Condition code
Cancer 314747 314747 0 0
Pancreatic
Physical Medicine / Rehabilitation 316821 316821 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is scheduled for a maximum period of 6 months, which will be terminated prior to surgical resection or at completion/permanent discontinuation of participants' prescribed neoadjuvant therapy. Participants in the intervention group will undertake supervised exercise training in the VARIO Health Clinic located at Edith Cowan University (ECU) Joondalup Campus and the Sport and Fitness Centre at ECU Mount Lawley campus at a frequency of two sessions per week with 45-60 minutes/session. For each session, participants will perform 20-30 minutes of resistance training, with the addition of either a maximum of 20 minutes of aerobic exercise or adapted sport-related drills, which will be alternated from session to session. All the prescribed exercise components in a session will be performed in a one-on-one manner or in a small group (based on participants' training schedule/availability) and closely supervised by the investigator. The training program will follow the principle of progressive overload. In addition, individual physical and psychological status on a specific training day will be taken into account in order that appropriate exercise volume and intensity are adopted to facilitate session adherence and ensure safety participation. Each session will commence with a 5-minute warm-up that includes low-intensity aerobic exercise and end with a 5-minute cool-down consisting of static stretches for the major muscle groups of the upper- and lower-body.

- Resistance training
Resistance training consists of four to six exercises that cover the major muscle groups of the upper- and lower-body using machines and dumbbells (such as overhead press, pull-down, chest press, seated row, leg press, and leg curl). For each exercise, participants will perform 1-3 sets at 8-12 repetition maximum (RM). The weight will be increased by 5-10% when a participant can successfully complete two additional repetitions on the last set of an exercise for two consecutive sessions.

- Aerobic exercise
A maximum 20-minute aerobic exercise bout will be performed by participants in every other session. The regime involves continuous cycle ergometer (upright or recumbent) exercise at an intensity of ~65-80% of estimated maximum heart rate (MHR) (MHR = 220-age), corresponding to the rating of perceived exertion (RPE) of 4-5 (Moderate to Hard) as measured by the 10-point Borg Category-ratio scale. The participants will be instructed to cycle with a pedaling speed of 50-80rpm. Throughout the intervention period, the exercise will be progressed by an increase in resistance and duration.

- Sport-related drills
Sport-related drills involve intermittent, moderate-intensity activities with rest intervals between adjacent activity bouts. Various upper- and lower-body dominant activities will be provided to the patients based on their personal circumstance. For example, participants can undertake acute bouts of repeated punches thrown or agility ladder drills for 30-60 seconds with 1 to 2 minutes of recovery between bouts. A target heart rate zone of ~65-80% of estimated MHR is anticipated to be achieved through training, corresponding to RPE of 4-5 on the 10-point Borg scale. Exercise mode, volume and intensity will be modified to elicit target heart rate zone and RPE.

To assess the intervention fidelity, a combination of heart rate sensor (Polar H10) and RPE (the 10-point Borg scale) will be used to monitor the activity profile of aerobic exercise and sport-related drills. For resistance training, beyond documentation of actually completed dose intensity (such as the number of exercises, sets, repetitions, and weights), RPE will also be recorded immediately after the completion of resistance training to assess the perceived intensity of the exercise bout. The relevant data will be documented in a preestablished training logbook by the investigator.
Intervention code [1] 317018 0
Treatment: Other
Comparator / control treatment
Active control with standard neoadjuvant therapy for locally advanced pancreatic cancer. In addition, the control group will receive a printed exercise booklet developed by Cancer Council Australia, which includes general advice on physical activity or home-based exercises following a cancer diagnosis. However, it is at the patients’ own discretion on exercise uptake and no specific prescription will be provided to them.
Control group
Active

Outcomes
Primary outcome [1] 324610 0
Safety as measured by the incidence and severity/nature of adverse events (AEs) for all participants recorded by the investigator, study clinicians and participants themselves in a logbook or medical records throughout the intervention period, including intervention-related AEs (such as muscle strain and ankle sprain) and non-intervention related AEs (such as neuropathy, diarrhea, and vomit)
Timepoint [1] 324610 0
Actively monitored during the intervention period (maximum 6 months post-intervention commencement)
Primary outcome [2] 324611 0
Feasibility as measured by the eligibility, recruitment, and attrition/retention rates of the study as well as the attendance and compliance rates of the program (intervention group only) that are determined by the recorded data in the training logbook
Timepoint [2] 324611 0
- Eligibility and recruitment rates assessed only at baseline
- Attrition/retention rate assessed at a potential midpoint (~4 months post-intervention commencement) and at the completion of the intervention (maximum 6 months post-intervention commencement
- Session attendance rate and program compliance rate assessed in each of the prescribed sessions
Secondary outcome [1] 385197 0
Cardiorespiratory fitness as measured using the 400-meter walk test
Timepoint [1] 385197 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [2] 385198 0
Dynamic balance control as assessed using a timed 6-meter backwards tandem walk
Timepoint [2] 385198 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [3] 385199 0
Lower extremity functional performance as measured using the repeated chair rise test
Timepoint [3] 385199 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [4] 385200 0
Muscle strength as measured collectively by the one-repetition maximum (1RM) chest press and leg press tests
Timepoint [4] 385200 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [5] 385201 0
Body composition determined collectively by whole-body lean mass, fat mass and percentage body fat and measured using dual-energy x-ray absorptiometry
Timepoint [5] 385201 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [6] 385202 0
Quality of life measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core module (EORTC QLQ-C30) in conjunction with the disease-specific module (EORTC QLQ-PAN26)
Timepoint [6] 385202 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [7] 385203 0
Cancer-related fatigue measured by the EORTC QLQ-C30 in conjunction with the EORTC QLQ-FA12 questionnaire
Timepoint [7] 385203 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [8] 385204 0
Psychological distress measured using the Brief Symptom Inventory-18 questionnaire
Timepoint [8] 385204 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [9] 385205 0
Surgical resection rate assessed as the proportion of the study patients who achieve resectability as defined by the Australiasian Gastro-Intestinal Trials Group and who proceed to elective surgical resection; the relevant data will be obtained from participants' medical records
Timepoint [9] 385205 0
At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [10] 385206 0
R0 resection rate examined as the proportion of the study patients who undergo elective surgical resection with clear margin (defined as >1mm); the relevant data will be obtained from participants' medical records
Timepoint [10] 385206 0
At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [11] 385207 0
Tumour progression measured using imaging scans (e.g., PET-CT and MRI) and/or blood biomarkers (e.g., carbohydrate antigen 19-9)
Timepoint [11] 385207 0
At the potential midpoint (~4 months post-intervention commencement), the completion of the intervention (maximum 6 months post-intervention commencement), and six months after the post-intervention assessment
Secondary outcome [12] 385208 0
Progression-free survival as measured by the length of time elapsed between intervention initiation and tumour progression or death from any cause
Timepoint [12] 385208 0
At the potential midpoint (~4 months post-intervention commencement), the completion of the intervention (maximum 6 months post-intervention commencement), and six months after the post-intervention assessment
Secondary outcome [13] 385209 0
Chemotherapy completion rate assessed as the average relative dose intensity (RDI) by chemotherapy regimens; the relevant data will be obtained from participants' medical records
Timepoint [13] 385209 0
At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [14] 385210 0
Hematological toxicity of the prescribed chemotherapy determined by composite evaluation of blood profile, including erythrocyte, leukocyte and thrombocyte counts and hemoglobin concentration
Timepoint [14] 385210 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [15] 385211 0
Length of hospital stay measured as the duration of a single episode of hospitalisation in patients who undergo elective surgical resection; the relevant data will be obtained from participants' medical records
Timepoint [15] 385211 0
At six months after the post-intervention assessment (maximum 12 months post-intervention commencement)
Secondary outcome [16] 385212 0
Resumption of activities of daily living as measured by a modified Resumption of Activities of Daily Living Scale in patients who undergo elective surgery
Timepoint [16] 385212 0
At six months after the post-intervention assessment (maximum 12 months post-intervention commencement)
Secondary outcome [17] 385216 0
The views of participants towards the sport-related component in the program as examined by the Physical Activity Enjoyment Scale (PACES)
Timepoint [17] 385216 0
At the completion of the intervention (maximum 6 months post-intervention commencement)
Secondary outcome [18] 385217 0
Physical activity level as measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire
Timepoint [18] 385217 0
At baseline, potential midpoint (~4 months post-intervention commencement), and at the completion of the intervention (maximum 6 months post-intervention commencement)

Eligibility
Key inclusion criteria
Patients diagnosed with borderline resectable or locally advanced pancreatic adenocarcinoma as per the definition proposed by the Australasian Gastro-Intestinal Trials Group and waiting to commence or within four weeks after starting their prescribed chemotherapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment for another primary cancer within the last 12 months, or another ongoing active primary malignancy;
- Recurrent pancreatic cancer with or without exposure to previous chemotherapy
- Anticipating to undergo major surgery for non-cancer diseases within six months
- Participating in structured exercise training greater than or equal to 2 days/week in the previous month
- ECOG (Eastern Cooperative Oncology Group) performance score greater than 1
- Contraindications to exercise training at moderate intensity

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
WA
Recruitment hospital [1] 17183 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 17184 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 30886 0
6009 - Nedlands
Recruitment postcode(s) [2] 30887 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 305134 0
University
Name [1] 305134 0
Edith Cowan University
Address [1] 305134 0
270 Joondalup Drive, Joondalup, WA 6027
Country [1] 305134 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 305494 0
None
Name [1] 305494 0
Address [1] 305494 0
Country [1] 305494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305504 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 305504 0
Level 2 A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 305504 0
Australia
Date submitted for ethics approval [1] 305504 0
27/03/2020
Approval date [1] 305504 0
Ethics approval number [1] 305504 0
Ethics committee name [2] 306989 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 306989 0
St John of God Health Care HREC, c/o 12 Salvado Road, Subiaco, WA 6008
Ethics committee country [2] 306989 0
Australia
Date submitted for ethics approval [2] 306989 0
11/09/2020
Approval date [2] 306989 0
16/10/2020
Ethics approval number [2] 306989 0
Reference number: 1726

Summary
Brief summary
This research project is to investigate the feasibility and efficacy of a multi-component exercise program in patients with borderline removable or locally advanced (irremovable) pancreatic cancer receiving preoperative therapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over, have a diagnosis of borderline removable or locally advanced pancreatic cancer, and are scheduled to receive or within four weeks after starting the neoadjuvant chemotherapy.

Study details:
Eligible participants will be randomly allocated 1:1 to either an intervention group or a usual care control group. The intervention group will undertake supervised exercise training for a maximum period of 6 months along with their neoadjuvant therapy, while participants in the control group will receive usual care and be offered advice on physical activity through a printed exercise booklet. The intervention group will be required to attend two sessions per week for 45-60 minutes/session. In each session, participants will perform 20-30 minutes of resistance training, with the addition of either a maximum of 20 minutes of aerobic exercise or adapted sport-related activities/drills, which will be alternated from session to session.

All participants will be closely monitored by the investigator, study clinicians and themselves throughout the intervention period for adverse events and other feasibility variables. In addition, they will undergo assessments at baseline (prior to intervention) and post-intervention (prior to elective surgical resection or at completion/permanent discontinuation of prescribed neoadjuvant therapy) for physiological and psychosocial outcomes as well as for a range of clinical-relevant outcomes. For patients with more than four months of neoadjuvant therapy and potentially distinct treatment modalities (i.e., chemotherapy and chemoradiation), an additional assessment will be scheduled before the alteration of treatment modality (~4 months post-intervention commencement). All participants will be followed-up for 6 months after completion of the post-intervention tests.

This study will provide information on the feasibility of the exercise program and its preliminary efficacy in patients with borderline resectable or locally advanced pancreatic cancer receiving preoperative therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100594 0
Mr Hao Luo
Address 100594 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 100594 0
Australia
Phone 100594 0
+61 8 6304 3444
Fax 100594 0
Email 100594 0
hluo1@our.ecu.edu.au
Contact person for public queries
Name 100595 0
Mr Hao Luo
Address 100595 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 100595 0
Australia
Phone 100595 0
+61 8 6304 3444
Fax 100595 0
Email 100595 0
hluo1@our.ecu.edu.au
Contact person for scientific queries
Name 100596 0
Mr Hao Luo
Address 100596 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 100596 0
Australia
Phone 100596 0
+61 8 6304 3444
Fax 100596 0
Email 100596 0
hluo1@our.ecu.edu.au

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?
No other documents available
Summary results
No Results