None listed
Conditions
Brief summary
Cancer cachexia is a complex, multifaceted syndrome that remains both challenging to diagnose and treat. In addition to negatively impacting patients’ quality of life and decreasing physical function, cachexia may worsen cancer treatment side-effects and significantly impact patient prognosis. Exercise has been shown to be an effective strategy to manage the adverse effects of cancer and its treatment. However, whether these benefits extend to individuals with cancer cachexia has been underexplored. This project will therefore aim to evaluate whether an individualised, 12 week supervised exercise training program is safe, feasible and effective as a management strategy for cancer cachexia. Who is this study for? You may be eligible to join this study if you have a diagnosis of locally advanced or metastatic cancer and are experiencing involuntary weight loss. Study details: Participants will be randomly assigned (by chance) to one of two groups: 1) an immediate exercise group; or 2) a delayed exercise group. Both groups will continue to receive standard medical care. The immediate exercise group will commence a 12 week exercise program (36 sessions) plus protein supplementation (three days/week) immediately following enrollment. The delayed exercise group will receive usual care (i.e. no change to their current lifestyle) following enrollment and will be offered participation in an identical exercise intervention 12 weeks after randomisation. In-person testing will be conducted at baseline, 12-weeks and 24 weeks. Testing will involve, strength and aerobic tests, a body scan, questionnaires and a fasted blood sample. Questionnaires will also be administered at 6-weeks but can be completed at home (online or paper copies). In addition, participants will be invited to complete optional assessments, which involve providing a muscle biopsy (sample of muscle tissue) and/or an evaluation of resting metabolic rate. This research is a critical first step in to determine the most feasible and effective ways to utilise exercise as a strategy to counteract the burden of cachexia in individuals with advanced cancer and therefore lay the foundation for future research.
Interventions
The intervention will include supervised, small group-based (1-4 participants) aerobic and resistance exercise training three times per week over a 12 week period. Exercise sessions will be led by exercise physiologists who have experience working with individuals with cancer and will be delivered in community fitness centers. Continuous aerobic exercise will be performed on a stationary exercise bike or treadmill for 10-20 minutes at 55-65% estimated heart rate maximum (HRmax), or a Borg rating
The intervention will include supervised, small group-based (1-4 participants) aerobic and resistance exercise training three times per week over a 12 week period. Exercise sessions will be led by exercise physiologists who have experience working with individuals with cancer and will be delivered in community fitness centers. Continuous aerobic exercise will be performed on a stationary exercise bike or treadmill for 10-20 minutes at 55-65% estimated heart rate maximum (HRmax), or a Borg rating of perceived exertion (RPE) of 12-13 out of 20, for the first two weeks and will progress to moderate intensity interval training at 70-80% HRmax, or an RPE of 15-16. High intensity interval training sessions at 85-95% HRmax, or RPE of 18-19, will be introduced in week four. Resistance exercise will include up to six exercises to target major upper and lower body muscle groups (e.g. leg press, chest press, seated row) using machines, free weights or body weight. Resistance exercise will start at two sets at 10-12 repetition maximum (RM), progressing to 3-4 sets of 6-10 RM by week nine. Exercise will be modified and progressed according to individual tolerability. Compliance and attendance (including the reasons for missed sessions or inability to meet exercise targets) will be tracked throughout the intervention by the supervising exercise physiologist. A 30 g serving of whey protein isolate powder (26 g of protein) mixed with 250-300 mL of water will be provided to all participants following each exercise session. Exercise physiologists will administer the protein supplement and track adherence. Subgroup analyses will be performed on a select number of intervention and usual care participants who choose to opt-in to additional assessments upon enrollment in the trial.
Sponsors
Mary MacKillop Institute for Health Research, Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of advanced cancer (i.e. locally advanced or metastatic disease) 2. Body mass index (BMI) <30 mg/m2 3. Australian-modified Karnofsky Performance Status >70 4. Weight loss >5% within the past 6 months, or BMI <20 kg/m2 and weight loss >2% within the past 6 months, or presence of sarcopenia and weight loss >2% within the past 6 months
Exclusion criteria
1. Refractory cachexia 2. Expected survival <3 months 3. Receiving parenteral nutrition or enteral nutrition via feeding tube 4. Scheduled to undergo surgery within the study period 5. Neuroendocrine carcinoma (e.g. neuroendocrine pancreatic cancer) 6. Use of mobility aids including a brace, cane walker or wheelchair 7. Contraindication to exercise as determined by treating medical physician (e.g. uncontrolled medical condition) 8. Inability to read and communicate in English
Outcome results
None listed