The PREVENT study: Does PRE-habilitation improVe pErformance status in uN-resectable stage III non-small cell lung cancer (NSCLC) patients undergoing chemo-radioTherapy? - A pilot study

Not Applicable

• Conditions: Patients with un-resectable stage III non-small cell lung cancer (NSCLC) undergoing chemo-radiotherapy.; Cancer - Lung - Non small cell

• Registration Number: ACTRN12621001601820
• Lead Sponsor: Ballarat Health Services (Base Hospital) - Ballarat Central

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-24
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aerobic fitness will be determined by peak oxygen consumption (VO2peak), which will be estimated using a submaximal cardio-pulmonary exercise test (CPET) performed on an electronically braked cycle ergometer as per guidelines published by the American Heart Association (Balady et al., 2010).[Baseline and 8-weeks post-intervention commencement.];Functional capacity will be assessed using the 6-minute walk test (6MWT), following the guidelines set out by American Thoracic Society (2002).[Baseline and 8-weeks post-intervention commencement.]