None listed
Conditions
Brief summary
The purpose of this open-label, single-centre pilot randomised controlled trial (RCT) is to investigate the use of supervised moderate-to-high intensity exercise in patients with un-resectable stage III non-small cell lung cancer (NSCLC) undergoing chemo-radiotherapy. Who is this study for? You may be eligible to join this study if you are aged 18 years or above, and have previously untreated stage IIIA, IIIB, or IIIC NSCLC that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a multidisciplinary meeting. What are the specific details? Participants will be randomised (i.e. allocated by chance) to receive either an exercise program for the duration of chemo-radiotherapy treatment, or chemo-radiotherapy treatment alone. The exercise program will involve 20 minutes of moderate-to-high intensity aerobic exercise 3 times per week, which will be supervised by a qualified exercise physiologist. Prior to commencing treatment and 8 weeks after commencing the study, all participants will undergo a number of tests of lung function and physical fitness, as well as completion of questionnaires regarding quality of life, depression, anxiety, and investigation of any exercise- or treatment-related side effects. What are you hoping to find? It is hoped that this study may show that moderate-to-high intensity exercise therapy is a feasible, safe, and efficacious method for improving quality of life and cardio-respiratory health in patients undergoing chemo-radiotherapy for the treatment of stage III non-small cell lung cancer (NSCLC).
Interventions
Sessions will be individual and face-to-face, which will be held at the physiotherapy clinic at the Ballarat Regional Integrated Cancer Centre (BRICC) or Queen Elizabeth Centre. Each 50-minute mixed exercise session will consist of:
- 5-minute warm-up on stationary bike at self-selected pace.
- 20 minutes of aerobic exercise (i.e., treadmill jogging/running and cycling).
- 10 minutes of resistance exercise (e.g., bench press, leg press, etc.).
- 10 minutes of structured, assisted stretching (i.e
Sessions will be individual and face-to-face, which will be held at the physiotherapy clinic at the Ballarat Regional Integrated Cancer Centre (BRICC) or Queen Elizabeth Centre. Each 50-minute mixed exercise session will consist of: - 5-minute warm-up on stationary bike at self-selected pace. - 20 minutes of aerobic exercise (i.e., treadmill jogging/running and cycling). - 10 minutes of resistance exercise (e.g., bench press, leg press, etc.). - 10 minutes of structured, assisted stretching (i.e., upper body and lower body stretches). - 5-minute cool down. The length of the intervention will last the duration of the patient's chemo-radiation therapy, which will be for a minimum of at least 3 weeks and up to a maximum of 8 weeks. Training progression will be in consecutive 2-week epochs with increasing intensity determined by participant’s individual heart rate maximum (HRM): - Weeks 1 and 2: 2 x 50 minutes (up to 55% HRM) - Weeks 3 and 4: 3 x 50 minutes (up to 60% HRM) - Weeks 5 and 6: 3 x 50 minutes (up to 65% HRM) - Weeks 7 and 8: 3 x 50 minutes (up to 70% HRM) Adherence to the intervention will be monitored using a session attendance checklist, and individual programming will be guided by proprietary software [goXpro, Sydney, AU (https://www.goxpro.com/optin-454228331608376497106)].
Sponsors
Ballarat Health Services (Base Hospital) - Ballarat Central
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. Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8. 2. No evidence of metastatic disease by whole body PET/CT scan, diagnostic quality CT scan, and brain imaging 3. Have un-resectable disease, that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a thoracic multidisciplinary meeting. 4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Have adequate pulmonary function test (PFT) as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value. 6. Fulfill the guideline requirements in the APSS. 7. Have capacity to provide written informed consent for the trial.
Exclusion criteria
1. A women of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to treatment allocation. 2. Has small cell lung cancer. Mixed tumours will be categorized by the predominant cell type: if small cell elements are present, the participant is ineligible. 3. Has had documented weight loss >10% in the preceding 3 months. 4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Outcome results
None listed