Clinical trial NCT03978325: Preoperative Exercise for Patients Undergoing Complex Cancer Surgery
Official title: Preoperative Exercise to Improve Fitness in Patients Undergoing Complex Surgery for Cancer of the Lung or Oesophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Physical Activity
Surgery--Complications
Keywords: Prehabilitation
Exercise
Surgery
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
name: Irish Cancer Society
First posted: 2019-06-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period.

This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery.

Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.

Detailed description: Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery, evaluation of health economics, the impact of the programme on hospital costs.

This study will take the form of a randomised controlled trial aimed primarily at improving pre-operative fitness with high intensity interval training (HIIT). HIIT prescribes aerobic exercise which alternates between periods of high intensity training and active recovery. This form of exercise training stimulates greater improvements in cardiopulmonary fitness over short periods compared to continuous aerobic training and therefore may be ideally suited to exercise prehabilitation. The primary outcome, cardiopulmonary fitness, will be measured by cardiopulmonary exercise testing and explored further using a suite of pulmonary and physical performance measures. Secondary outcomes will examine the impact of individually prescribed HIIT on postoperative outcome, postoperative physical recovery, restoration of pre-treatment fitness levels and both acute and sub-acute hospital costs. The investigators anticipate that this mode of exercise prehabilitation will attenuate postoperative risk and improve postoperative recovery, thus improving patient quality of life and having considerable economic benefits for the healthcare system.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for either oesophagectomy (2-stage or 3-stage) or major lung resection for the management of primary oesophageal or lung cancer.
* Date of surgery ≥ 2 weeks from baseline assessment
* Ability to provide written informed consent
* Absence of significant co-morbidities, including metastatic disease, which may adversely impact postoperative outcome
* Successful completion of a medically supervised cardiopulmonary exercise test
* Patients with oesophageal cancer scheduled for multimodal therapy including preoperative chemo(radio)therapy and oesophagectomy will be recruited and tested prior to treatment commencement.

Exclusion Criteria:

* The American Thoracic Society/American College of Chest Physicians (ATS/ACCP) absolute contraindications for exercise testing will be applied.
* Patients undergoing video assisted lobectomy for early lung cancer will be excluded.

Primary outcomes:
measure: Change in Cardiorespiratory Fitness
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Secondary outcomes:
measure: Clavien-Dindo Scale
timeFrame: At hospital discharge (approximately 7-14 days postoperatively)
measure: Change in the Post-Operative Morbidity Score (POMS)
timeFrame: On postoperative day 5, postoperative day 7 and at hospital discharge (approximately 7-14 days postoperatively)
measure: The Comprehensive Classification Index (CCI)
timeFrame: At hospital discharge (approximately 7-14 days postoperatively)
measure: Change in Pulmonary function
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
measure: Change in Maximum Inspiratory pressure
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
measure: Change in Muscle strength
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
measure: Change in Self reported physical activity: International Physical Activity Questionnaire (IPAQ)
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) as well as post-operative day 30
measure: Change in Self reported functional recovery
timeFrame: At post-operative day 30
measure: Change in Functional Performance
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
measure: Change in Quality of Life
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
measure: Change in Quality of Life (Specific to Lung Cancer)
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
measure: Change in Quality of Life (Specific to Oesophageal Cancer)
timeFrame: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.
measure: Cost Effectiveness
timeFrame: At routine post-operative clinic visits at 6 weeks and 3 months postoperatively.
measure: Qualitative Approach
timeFrame: Immediately after the programme intervention (T1)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University of Dublin, Trinity College
Study officials:
affiliation: University of Dublin, Trinity College
name: Juliette Hussey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheill G, Guinan E, O'Neill L, Normand C, Doyle SL, Moore S, Newell J, McDermott G, Ryan R, Reynolds JV, Hussey J. Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial. BMC Cancer. 2020 Apr 15;20(1):321. doi: 10.1186/s12885-020-06795-4.