None listed
Conditions
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.
Interventions
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 at a frequency of two sessions per week with 45-60 minutes/session. Participants in Perth can undertake exercise in any of the five exercise clinics affiliated to Edith Cowan University (ECU). Participants in Sydney can undertake exercise at the exercise clinics in the Supportive Care and Integrative Oncology Department at Chris O’Brien Lifehouse. 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.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients diagnosed with high-risk resectable, 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 eight weeks after starting their prescribed chemotherapy
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 - Contraindications to exercise training at moderate intensity