FEV and/or DLCO \<80% And VO2peak \<20ml/kg.min or \<75% predicted value

FEV and DLCO \>80% and VO2peak \> 20ml/kg.min or \>75% predicted value

Alexis Gillet, Pt, Msc

Alexis Gillet, Msc

Forton Kevin, PhD

Kevin Forton, PhD

Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Scientific societies recommend a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this context, patients with FEV1 or less than 80% of the predicted value are subjected to a more thorough evaluation of the physical physical capacity by cardiopulmonary exercise test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max \<35% of predicted values or \<10ml/kg/min, or a postoperative predicted value of DLCO or FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35% or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli et al 2009).

For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent of the resection. In this group of patients, other parameters measured with CPET could be used to optimize the selection of patients given the inability of some the inability of some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of physical capacity.

The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters classically used in classically used in heart failure and have recently been shown to be independent prognostic factors as independent prognostic factors for 90-day and 2-year mortality after anatomical lung resection. Moreover, these factors do not depend on the maximality of the test and could again help us to risk-stratify for a sub-maximal and therefore not optimal test.

Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates

Interest of Maximal Oxygen Uptake and Ventilatory Inefficiency (VE/VCO2 Slope) Measured During Cardiopulmonary Exercise Test on Morbidity and Mortality of Lung Resection Candidates

pneumonia (chest roentgenogram infiltrates/consolidation, leukocytosis, fever)

* respiratory failure needng mechanical ventilation for longer than 48 hours, adult respiratory distress syndrome

air leak \>5 day (Patient experienced a postoperative air leak for \>5 days),atelectasis requiring bronchoscopy, atrial or ventricular arrhythmia, Empyema, Wound infection, delirium, renal failure

Université Libre de Bruxelles

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients randomised to exercise training will be offered three sessions of aerobic interval exercise per week over the subsequent 4 weeks prior to their procedure. Each session will comprise 6 x 5 min repetitions at 60-80% peak VO2, with 2.5 min rest intervals. The aim will be to quickly progress patients to exercise intensities that correspond to and exceed the individual AT. Heart rate, clinical signs, blood pressure and perceived exertion will be recorded regularly throughout exercise.

Repeat CPET testing will then take place 4 weeks from the baseline test in the exercise laboratory (on the day prior to surgery) to determine changes (if any) in AT, VO2, VE/VCO2.

The patients in the non-exercise arm of the study will not undergo any exercise intervention but will be CPET tested in the exercise laboratory at the same time points as the exercise arm patients.

Exercise training

Kate Manley, MBBS

John Saxton

James Hernon

Jurgens Nortje

Kate Manley

Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia to look at the role of exercise before surgery to improve recovery following an operation.

Having an operation to remove part of the bowel puts physical stress on the body. We know that training can help the body cope with physical stress in the same way that an athlete trains before a competition. We hypothesise that the body may recover more quickly if it is trained prior to an operation with regular and simple exercises.

Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart and muscles at rest and during exercise. CPET testing is often done as part of standard pre-operative assessment in many hospitals for patients before undergoing major surgery. Some studies have demonstrated that CPET can be used to predict outcomes following surgery (such as time taken till discharge, complication rates).

The study consists of two parts:

Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to determine baseline fitness. Blood tests will be taken around the time of surgery to examine whether biochemical markers in the bloodstream (when used in combination with results from the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will then be monitored to assess their speed of recovery and rate of complications following surgery.

This will enable us to determine which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery.

2) The second study will consist of an exercise intervention involving several sessions of supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET measurements will be taken to see if fitness has improved with exercise.

This part of of the study is to determine if it is feasible to implement a structured, supervised exercise programme for patients awaiting elective colorectal cancer surgery. The results of this study will be used to inform a larger randomised controlled trial to examine the influence of exercise on CPET variables and postoperative outcomes.

The study will be conducted in two parts:

Part 1. Study to examine the ability of CPET to predict outcomes in patients undergoing colorectal surgery:

Objectives

To identify which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery. In addition, to examine whether CPET variables can be used in combination with other scoring systems or blood tests to increase accuracy of prediction. The aim of this investigation is to develop an accurate prediction model from key clinically relevant predictor variables, including CPET variables, blood tests and risk scoring systems. Such a model could be used in clinical practice to predict pre-operative outcome and thus help risk stratify patients for post-operative surveillance or management.

Study Population

The Norfolk and Norwich University Hospital undertakes approximately 300 procedures for colorectal cancers per year. Patients scheduled for cancer surgery will be recruited to the trial.

Study Outline

Informed consent to participate in the trial will be obtained in the outpatient setting after diagnosis/scheduling of surgery through discussion with the medical team and the colorectal nurse specialists. All patients will follow a standardised peri-operative pathway devised in conjunction with the surgical and anaesthetic team.

Sample Size

A sample size of a minimum of 90 patients has been identified, based on comparable studies with other patient groups in the literature.

Predictor Variables

Supervised pre-operative CPET testing will take place in the exercise laboratory at the University of East Anglia before surgery. The test is done by pedalling on a stationary bicycle, the resistance to pedalling will gradually increase, similar to when cycling up a hill. As the subject rides the stationary bike, the amount of oxygen used, and how fast/efficiently their heart beats is calculated. Breathing will be measured through a face mask or a mouth piece and the electrical activity of the heart will be measured via sensors placed on the chest. Each CPET test takes around 30 minutes to complete. For each participant in this part of the study, only one CPET test will be done prior to surgery at a convenient time.

In addition to the standard pre-surgery blood tests that all NHS patients receive, blood will be taken to measure several key serum markers which have been associated with post-operative outcomes in patients undergoing major abdominal surgery (pro-BNP, CRP, albumin and IL-6).

Scoring systems will be applied to patient data as additional indicators of peri-operative risk - these are systems which involve calculating a measure of risk based on other co-existing illnesses the patient may have.

Data Collection

Patient notes will be reviewed on each postoperative day to identify postoperative complications according to the Post-Operative Morbidity Survey system (POMS), this is a scoring tool previously used in other studies which assesses different systems of the body to determine 'morbidity' according to defined criteria (pulmonary, infection, renal, gastrointestinal, cardiovascular, wound complications, haematological and pain. Time taken until pain relief is satisfactory, ability to eat and drink, satisfactory level of mobility/self-care and bowel function will also be recorded. Length of hospital stay and time taken until the patient is medically fit for discharge will also be recorded.

Part 2: Feasibility of a randomised prehabilitation programme in patients undergoing surgery for colorectal cancer

Objectives

To determine the feasibility of implementing a structured, supervised exercise programme for patients awaiting elective colorectal cancer surgery. The results of this study will be used to inform a larger randomised controlled trial to examine the influence of exercise on CPET variables and postoperative outcomes.

Study Population (as above)

Study Outline

Following baseline CPET testing to assess initial background fitness, patients will be randomised to one of two study arms:

1. a supervised aerobic exercise training pathway + standard treatment or
2. standard treatment without supervised exercise training

To adequately assess key feasibility outcomes, a sample size of 60 patients (30 in each arm of the study) will be used.

Patients randomised to exercise training will be offered three sessions of supervised aerobic exercise per week over the subsequent 4 weeks before their procedure to be conducted in the exercise lab at the University of East Anglia.

Each session will include a few simple freehand exercises as well as some time on the treadmill or a fixed exercise bike. The sessions will last about an hour each and will be tailored to individual fitness levels. Heart rate, clinical signs, blood pressure and perceived exertion will be recorded regularly throughout exercise. This exercise protocol is currently in use in a study of elderly patients with bladder cancer awaiting surgery and is well-tolerated.

Repeat CPET testing will then take place 4 weeks from the baseline test in the exercise laboratory (on the day prior to surgery) to determine changes (if any) in CPET variables.

The patients in the non-exercise arm of the study will not undergo any exercise intervention but will be CPET tested in the exercise laboratory at the same time points as the exercise arm patients. The data from these patients (n=30) will be used to contribute to the first part of the study (CPET variables as predictors of outcome).

All patients will be CPET tested again at 3 months post-surgery to assess how well they have returned to their baseline function following their operation. Patients will be given follow-up questionnaires at this time, and again at 6 months post-surgery to assess health-related quality of life and psychological outcomes. The questionnaires used will be: CHAMPS Physical Activity Questionnaire for older adults, The Satisfaction with Life Scale, Hospital Anxiety and Depression Scale (HADS), FACT-F and the FACT-C scale to assess disease-specific quality of life.

Data collection:

As before, patient notes will be reviewed and post-operative complications identified. In addition, this study will assess the feasibility of conducting this trial on a larger scale: to identify the number of eligible patients, recruitment rate, willingness of patients to be randomised, willingness of clinicians to participate in the trial, compliance/tolerance of the exercise regimen, and patient satisfaction with the process. In addition, the costs of undergoing CPET testing and supervised exercise training will be estimated.

An assessment of key health outcomes will also be undertaken, i.e. changes in CPET variables following exercise training, postoperative complications, length of stay, and health-related quality of life benefits, thus enabling the planning of a larger trial.

Preop CPET Testing and Exercise Training in Colorectal Patients

An Investigation Into the Role of Cardiopulmonary Exercise Testing and Pre-operative Exercise Training in Patients Undergoing Major Surgery for Colorectal Cancer

The primary outcomes of this study are to assess the feasibility of conducting this trial on a larger scale: to identify the number of eligible patients, recruitment rate, willingness of patients to be randomised, willingness of clinicians to participate in the trial, compliance/tolerance of the exercise regimen, patient satisfaction with the process and attrition. In addition, the costs of undergoing CPET testing and supervised exercise training will be estimated.

An assessment of the characteristics/variability of key health outcomes will also be undertaken, i.e. changes in CPET variables following exercise training, postoperative complications, length of stay, and health-related quality of life benefits, thus enabling identification of a suitable primary outcome measure and sample size calculation for a larger trial.

Patient notes will be reviewed on each postoperative day to identify incidence of postoperative complications according to the Post-Operative Morbidity Survey system (POMS), a validated 18-item scoring tool which assesses nine domains of morbidity relevant to the post-surgical patient according to precisely defined criteria (pulmonary, infection, renal, gastrointestinal, cardiovascular, wound complications, haematological and pain.

total postoperative hospital stay (days postop), (including the length of stay for those patients who are readmitted to hospital within 30 days of their surgery),

mortality in the first 30 days following surgery will be recorded

The need for transfer from ward-level care to higher level care (high dependency or intensive care) following surgery

National Institute for Health Research, United Kingdom

University of East Anglia

Symptoms and General Pathology

Behaviors and Mental Disorders

Fatigue

Quality of Life

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Patients will attend the 16-week program of boxing conditioning.
* This 16-week program will include supervised exercises designed to improve strength, flexibility, balance,and cardiopulmonary fitness.
* There will be 4, 1-hour sessions each week per participant

H4H fitness program

Elizabeth O'Donnell, MD

This research study is assessing the effect of an exercise program on cancer survivors.

The exercise program is Haymakers for Hope 16-week exercise program

This is a pilot study, it is the first time investigators are examining the effect of this exercise program on cancer survivors physical and emotional functioning. The exercise programs is based on the conditioning program used by boxers.- Haymakers for Hope 16-week exercise program

* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Participants will attend the 16-week program of boxing conditioning. It is expected that about 10 people will take part in this research study.

  * This 16 week will include supervised exercises designed to improve strength, flexibility, balance and cardiopulmonary fitness.
  * There will be 4 sessions of 1 hour each week for each of the 10 participants.
  * The program will be conducted at gymnasiums contracted with the H4H program and outcomes assessments at Massachusetts General Hospital and the gymnasiums..

Pilot Study of the Haymakers for Hope Fitness Program

A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors

Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions

Feasibility will be demonstrated if ≥60% of participants complete the fitness program

summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL).

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL)

Haymakers for Hope

Massachusetts General Hospital

Principal Investigator

Skin and Connective Tissue Diseases

Infections

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Squamous Cell

Melanoma, Cutaneous Malignant

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Adenocarcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.

Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.

Exercise Test

Recruitment Department

Bret Goodpaster, PhD

Tarek Mekhail, MD

The purpose of this pilot study will be to provide i) information on feasibility implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention.

We will use stratified block randomization to assure non-biased assignment to the exercise intervention arm. Within each treatment setting, adjuvant and neoadjuvant, 10 patients will be randomized to the exercise intervention arm and 10 to the standard treatment arm. Within the neoadjuvant setting, randomization also will be blocked within disease type.

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy.

Recurrence-free survival will be assessed.

For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy.

This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates	NCT05502263	Exercise Test Thoracic Cancer		18 Years -	Université Libre de Bruxelles
Preop CPET Testing and Exercise Training in Colorectal Patients	NCT01924897	Colorectal Neop...	Exercise traini...	18 Years -	University of East Anglia
Pilot Study of the Haymakers for Hope Fitness Program	NCT04220216	Cancer Exercise Test Fatigue Mood Quality of Life Biomarkers	H4H fitness pro...	18 Years -	Massachusetts General Hospital
Pilot Study of the Haymakers for Hope Fitness Program	NCT04220216	Cancer Exercise Test Fatigue Mood Quality of Life Biomarkers	H4H fitness pro...	18 Years -	Massachusetts General Hospital
Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates	NCT05502263	Exercise Test Thoracic Cancer		18 Years -	Université Libre de Bruxelles
Exercise to Boost Response to Checkpoint Blockade Immunotherapy	NCT06008977	Cutaneous Melan... Cutaneous Squam... Merkel Cell Car...	Exercise Test	18 Years -	AdventHealth Translational Research Institute

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