Virtual Exercise Program for Lung Cancer

Overseen By Tracy Green

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Active malignancy, Pregnancy, Extreme fatigue, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual exercise program designed for people with non-small cell lung cancer. The goal is to determine if this digital platform can improve physical function and overall outcomes for participants. It targets those about to start treatment or in various stages of their cancer journey, including post-surgery or during chemotherapy and radiation. Participants should commit to using a virtual exercise platform, specifically the Salaso Virtual Exercise Program, and have non-small cell lung cancer. The trial aims to assess the feasibility and user-friendliness of this exercise program for patients. As an unphased trial, this study explores innovative ways to enhance the cancer treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a virtual exercise program for lung cancer patients.

What prior data suggests that this virtual exercise program is safe for lung cancer patients?

Research has shown that virtual exercise programs, such as the Salaso Virtual Exercise Program, are generally well-received by lung cancer patients. One study on a 12-week virtual exercise program for patients with advanced lung cancer found that participants attended regularly and followed the program well, indicating its manageability. This study also found significant improvements in participants' physical abilities. Although specific safety information on the Salaso Virtual Exercise Program is limited, positive results from similar programs suggest it is likely safe. Participants experienced improvements without any major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Salaso Virtual Exercise Program for lung cancer patients because it offers a unique approach to enhancing recovery and quality of life. Unlike traditional treatments like chemotherapy, surgery, or radiation, this program focuses on integrating virtual exercise into the patient's care plan. This innovative method leverages technology to provide personalized, accessible exercise routines that can be tailored to each patient's needs, regardless of their location. By potentially improving physical fitness and mental well-being during and after treatment, this program could offer significant benefits that complement standard medical therapies.

What evidence suggests that this virtual exercise program is effective for lung cancer?

Research has shown that online exercise programs can benefit people with lung cancer. In one study, patients with advanced lung cancer participated in a 12-week online exercise program and demonstrated high participation and noticeable improvements in physical abilities. Another study found that 80% of participants completed an 8-week exercise program, proving its practicality and benefits. These programs often improve lung function and overall quality of life for lung cancer patients. This trial will evaluate the Salaso Virtual Exercise Program, which suggests that exercising through an online platform could lead to better health outcomes for lung cancer patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for lung cancer patients at R.J. Zuckerberg Cancer Center who can perform exercises virtually and commit to a 12-month program. It's open to those with Non-small cell lung cancer, an ECOG performance status of 0-2, able to consent, and deemed appropriate by the PM&R team. There are three cohorts: peri-operative patients, those starting chemotherapy and radiation for advanced cancer, and stage IV metastatic patients.

Inclusion Criteria

I am able to care for myself and up and about more than 50% of my waking hours.

Are deemed appropriate for virtual exercise program by the PM&R team

English speaking

Exclusion Criteria

Any contraindication to participating physically in an exercise program

Pregnant or breastfeeding at the time of screening visit

Lack of proficiency in English sufficient for comprehension of trial source documents including the protocol, consent, and questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Baseline Assessment

Participants undergo pulmonary function test, Six minute walk test (6MWT), and Sit to Stand Test (STS) if not previously completed within 3 months of signing consent

1 week

1 visit (in-person)

Virtual Exercise Program

Participants engage in a virtual personalized exercise program tailored to their needs, accessible through a digital platform

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the exercise program, including quality of life assessments and provider satisfaction

12 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Salaso Virtual Exercise Program

Trial Overview The Salaso Virtual Exercise Program is being tested for its feasibility and impact on lung cancer patients' functional status and quality of life. Participants will use a digital platform for personalized exercise regimens over a year, with evaluations including pulmonary function tests, walking endurance tests (6MWT), strength assessments (STS), and satisfaction surveys.

How Is the Trial Designed?

Group I: Single Arm Study Experimental Treatment 1 Intervention

Cohort A: Peri-operative (subjects starting neoadjuvant chemotherapy or within 4-8 weeks after curative-intent thoracic surgery which could be segmentectomy, lobectomy of pneumonectomy), irrespective of adjuvant treatment - expected recruitment: 15 subjects Cohort B: Subjects Subjects starting definitive chemotherapy and radiation for locally advanced lung cancer- expected recruitment: 15 subjects Cohort C: Subjects with stage IV metastatic non-small cell lung cancer irrespective of type of treatment - expected recruitment: 30 subjects

Salaso Virtual Exercise Program is already approved in United States for the following indications:

Approved in United States as Salaso Virtual Exercise Program for:

• Rehabilitation for lung cancer patients

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Salaso

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

This study will evaluate a 12-week exercise program for 216 patients with advanced lung cancer, focusing on improving physical capacity and quality of life through supervised cardiovascular and strength training.

The primary outcome measured will be maximal oxygen uptake (VO₂peak), with secondary outcomes including muscle strength, functional capacity, lung capacity, and patient-reported anxiety and depression, aiming to provide evidence on the benefits of exercise in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. Quist, M., Langer, SW., Rørth, M., et al.[2021]

The study assessed the feasibility of an 8-week hospital-based exercise program for 25 patients with advanced non-small cell lung cancer, finding that while 80% started the program, only 44% completed all sessions.

Patients who completed the exercise program reported significant improvements in lung cancer symptoms without any decline in their functional capacity, suggesting that structured exercise can be beneficial for those who can adhere to it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured exercise program for patients with advanced non-small cell lung cancer. Temel, JS., Greer, JA., Goldberg, S., et al.[2021]

The LUNGEVITY trial will evaluate the effects of different exercise training types on cardiorespiratory fitness (VO2peak) and patient-reported outcomes in 160 post-operative non-small cell lung cancer patients over 16 weeks.

The study aims to determine the most effective exercise regimen (aerobic, resistance, or a combination) for improving fitness and quality of life, which could lead to new rehabilitation guidelines for lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. Jones, LW., Eves, ND., Kraus, WE., et al.[2021]

Exercise training can significantly improve exercise capacity in individuals who have undergone lung resection for non-small cell lung cancer (NSCLC), with a mean increase of 50.4 meters in the six-minute walk distance compared to control groups.

However, the evidence regarding improvements in health-related quality of life (HRQoL) and lung function (FEV1) was inconclusive, indicating that while exercise training may help with physical capacity, its effects on overall quality of life and lung function need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cavalheri, V., Tahirah, F., Nonoyama, M., et al.[2022]

Exercise can significantly benefit lung cancer patients by improving strength, endurance, and emotional well-being, regardless of the stage of their illness.

A structured recovery fitness program that includes breathing exercises, stretching, aerobic activities, and strength training is recommended to support lung cancer survivors and address their diverse needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. Michaels, C.[2020]

Exercise training is a safe and feasible adjunct therapy for patients with operable lung cancer, both before and after surgery, helping to improve their ability to tolerate exercise.

For patients with inoperable lung cancer, while more research is needed, preliminary evidence suggests that carefully prescribed exercise training could also be beneficial and should be considered in their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and lung cancer survivorship. Jones, LW.[2015]

Exercise training significantly improves exercise capacity in individuals who have undergone lung resection for non-small cell lung cancer (NSCLC), with increases in peak oxygen uptake (VO2peak) and six-minute walk distance (6MWD) observed in a review of eight randomized controlled trials involving 450 participants.

Participants who engaged in exercise training also reported better physical health-related quality of life (HRQoL) and reduced feelings of dyspnoea, highlighting the importance of incorporating exercise into postoperative care for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cavalheri, V., Burtin, C., Formico, VR., et al.[2021]

In a study of 41 lung cancer patients undergoing lung resection, those who participated in supervised systemic pulmonary rehabilitation (PR) showed significant improvements in pain and quality of life after more than 3 months, indicating the efficacy of this intervention.

Patients receiving systemic PR also demonstrated significant enhancements in forced vital capacity (FVC) after 6 months, suggesting that supervised rehabilitation can effectively aid recovery of lung function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Systemic Postoperative Pulmonary Rehabilitation After Lung Resection Surgery. Kim, SK., Ahn, YH., Yoon, JA., et al.[2020]

In a pilot study involving 40 patients with advanced stage lung cancer, a 3-month home-based walking program increased physical activity levels compared to usual care, suggesting that such interventions can be feasible and beneficial for this population.

The intervention also led to significant improvements in quality of life, particularly in the role functioning domain, and indicated potential biomarker changes, highlighting the need for further research on the relationship between physical activity and cancer biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". Bade, BC., Gan, G., Li, F., et al.[2023]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Telerehabilitation for lung cancer patients is safe and can improve quality of life, muscle mass, and reduce symptoms of depression and anxiety, although it does not significantly enhance physical capacity except in the preoperative phase.

Despite low recruitment and attendance rates, telerehabilitation serves as a valuable complementary intervention to traditional hospital-based programs, especially for patients unable to attend in-person training due to various barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation physical exercise for patients with lung cancer through the course of their disease: A systematic review. Burton, M., Valet, M., Caty, G., et al.[2022]

This pilot study will assess the feasibility of personalized virtual exercise training for 20 breast and prostate cancer survivors over 24 weeks, which includes 12 weeks of one-on-one training followed by 12 weeks of independent exercise using recorded sessions.

The study aims to evaluate the preliminary effects of this virtual program on various health metrics, such as body composition and exercise self-efficacy, potentially addressing barriers to physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. Shirazipour, CH., Ruggieri-Bacani, RM., Lockshon, L., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06540495/virtual-personalized-exercise-program-for-lung-cancer-patients

Virtual Personalized Exercise Program for Lung Cancer ... This is a prospective study providing lung cancer subjects at RJ Zuckerberg Cancer Center with a customized exercise program provided by Salaso.

2. withpower.com withpower.com/trial/phase-lung-cancers-5-2024-68e4d

Virtual Exercise Program for Lung Cancer The study assessed the feasibility of an 8-week hospital-based exercise program for 25 patients with advanced non-small cell lung cancer, finding that while 80% ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39919548/

Mitigation of decline with virtual exercise with lung cancer ... A 12-week virtually supervised exercise program for patients with advanced lung cancer showed high attendance and adherence, with significant improvements ...

4. ancora.ai ancora.ai/it/details/NCT06540495

Virtual Personalized Exercise Program for Lung Cancer ... This study will assess the feasibility and usability of a virtual exercise platform designed for lung cancer subjects. Subjects will be referred to physical ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19276834/

A structured exercise program for patients with advanced non ... In this study, we examined the feasibility of a hospital-based exercise program for patients with advanced non-small cell lung cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03649737

Exercise Program Among Lung Cancer Dyads Preliminary outcomes include objective measures of physical function, depression, adherence to lung cancer treatments, Quality of Life (QOL), and social support ...