ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pancreatic cancer

Condition category

Condition code

Cancer

Pancreatic

Physical Medicine / Rehabilitation

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]

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]

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]

Actively monitored during the intervention period (maximum 6 months post-intervention commencement)

Primary outcome [2]

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]

- 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]

Cardiorespiratory fitness as measured using the 400-meter walk test

Timepoint [1]

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]

Dynamic balance control as assessed using a timed 6-meter backwards tandem walk

Timepoint [2]

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]

Lower extremity functional performance as measured using the repeated chair rise test

Timepoint [3]

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]

Muscle strength as measured collectively by the one-repetition maximum (1RM) chest press and leg press tests

Timepoint [4]

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]

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]

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]

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]

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]

Cancer-related fatigue measured by the EORTC QLQ-C30 in conjunction with the EORTC QLQ-FA12 questionnaire

Timepoint [7]

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]

Psychological distress measured using the Brief Symptom Inventory-18 questionnaire

Timepoint [8]

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]

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]

At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)

Secondary outcome [10]

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]

At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)

Secondary outcome [11]

Tumour progression measured using imaging scans (e.g., PET-CT and MRI) and/or blood biomarkers (e.g., carbohydrate antigen 19-9)

Timepoint [11]

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]

Progression-free survival as measured by the length of time elapsed between intervention initiation and tumour progression or death from any cause

Timepoint [12]

Secondary outcome [13]

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]

At the potential midpoint (~4 months post-intervention commencement), and the completion of the intervention (maximum 6 months post-intervention commencement)

Secondary outcome [14]

Hematological toxicity of the prescribed chemotherapy determined by composite evaluation of blood profile, including erythrocyte, leukocyte and thrombocyte counts and hemoglobin concentration

Timepoint [14]

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]

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]

At six months after the post-intervention assessment (maximum 12 months post-intervention commencement)

Secondary outcome [16]

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]

At six months after the post-intervention assessment (maximum 12 months post-intervention commencement)

Secondary outcome [17]

The views of participants towards the sport-related component in the program as examined by the Physical Activity Enjoyment Scale (PACES)

Timepoint [17]

At the completion of the intervention (maximum 6 months post-intervention commencement)

Secondary outcome [18]

Physical activity level as measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire

Timepoint [18]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/11/2020

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)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [2]

St John of God Hospital, Subiaco - Subiaco

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Drive, Joondalup, WA 6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Drive, Joondalup, WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee

Ethics committee address [1]

Level 2 A Block, Hospital Ave, Nedlands, WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/03/2020

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

St John of God Health Care Human Research Ethics Committee

Ethics committee address [2]

St John of God Health Care HREC, c/o 12 Salvado Road, Subiaco, WA 6008

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

11/09/2020

Approval date [2]

16/10/2020

Ethics approval number [2]

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

Mr Hao Luo

Address

Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027

Country

Australia

Phone

+61 8 6304 3444

Fax

[email protected]

Contact person for public queries

Name

Mr Hao Luo

Address

Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027

Country

Australia

Phone

+61 8 6304 3444

Fax

[email protected]

Contact person for scientific queries

Name

Mr Hao Luo

Address

Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027

Country

Australia

Phone

+61 8 6304 3444

Fax

[email protected]

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?

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

Source	Title	Year of Publication	DOI
Embase	Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): Study protocol of a dual-centre, two-armed phase i randomised controlled trial.	2021	https://dx.doi.org/10.1136/bmjgast-2021-000642

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically