Pre-surgical Aerobic Exercise for Cancer

Not currently recruiting at 7 trial locations

Overseen By Jessica Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Estrogen modulators, Aromatase inhibitors, Antiandrogens, GNRH agonists

Disqualifiers: Metastatic malignancy, Invasive cancer, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safest amount of treadmill walking for individuals preparing for cancer surgery. Researchers aim to understand how different exercise levels affect patients and their cancer outcomes. Participants will engage in various exercise routines and use apps to track their activity. Those with breast, prostate, endometrial, or lung cancer who are not currently exercising much and are preparing for surgery might be suitable candidates. As an Early Phase 1 trial, this research seeks to understand how exercise impacts cancer patients, offering participants the opportunity to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial requires that you have not used certain medications like selective estrogen receptor modulators or aromatase inhibitors within 6 months before joining, and men should not be on GNRH agonists, antagonists, or antiandrogens. If you're on these medications, you may need to stop them to participate.

What prior data suggests that this aerobic exercise protocol is safe for cancer patients undergoing surgery?

Research shows that aerobic exercise, such as walking on a treadmill, is safe for individuals preparing for cancer surgery. Studies have found that exercising before surgery can enhance fitness and recovery. One study confirmed the safety of these exercise programs, noting that heart rate checks during exercise are accurate and safe.

Although this trial is in its early stages, with ongoing safety data collection, past research on similar exercise programs for cancer patients supports their safety. No major issues have been reported in connection with aerobic exercise in these situations.

In summary, walking on a treadmill as a form of aerobic exercise appears well-tolerated and safe for those preparing for surgery, based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prescribing pre-surgical treadmill walking for cancer patients because it's a non-invasive, drug-free approach that can complement traditional treatments like chemotherapy or surgery. Unlike conventional therapies that often focus directly on targeting cancer cells, this aerobic exercise regimen aims to improve overall physical fitness and potentially enhance recovery rates post-surgery. Additionally, this method is adaptable, with personalized exercise plans that can be adjusted based on individual patient needs, making it a versatile option for different types of cancer, including breast, prostate, endometrial, and lung cancer. The hope is that by boosting patients' strength and endurance before surgery, their bodies will be better equipped to handle the stress of treatment and recover more quickly.

What evidence suggests that aerobic exercise is effective for cancer patients undergoing surgery?

Research has shown that aerobic exercise, such as treadmill walking, can improve walking endurance and overall fitness for cancer patients. In this trial, participants will engage in individualized, progressive aerobic training through treadmill walking. One study found that exercising around the time of surgery enhanced heart and lung function and increased exercise capacity. However, another study suggested that exercising at home might not reduce surgery complications or shorten hospital stays. Despite these mixed results, many experts recommend exercise as part of cancer care to improve overall fitness. ^{1 2 6 7 8}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a BMI ≤ 40 who have been diagnosed with early-stage breast, endometrial, or prostate cancer and are scheduled for surgery. They should not be doing more than minimal structured exercise weekly and must be willing to follow study procedures including at-home exercise and lifestyle monitoring.

Inclusion Criteria

- If BMI >40, patients may be eligible, at the discretion of the PI

I have prostate cancer that has not been treated yet, but I am scheduled for surgery.

- Performing </= 30 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report. If > 30 minutes but less than 90 minutes, patients may be eligible, at the discretion of the PI.

Exclusion Criteria

I am a man taking hormone therapy for cancer.

Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

I am not part of any other clinical trials that could affect this study's results, except those approved by the study leader.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 0: Feasibility and Quality Assessment

Evaluate the feasibility and quality of at-home exercise and assessment procedures, including continuous lifestyle monitoring using apps and electronic devices.

2 weeks

At-home monitoring

Phase 1a: Dose-Finding / Escalation

Compare the effects and feasibility of six different doses of aerobic exercise, ranging from 90 mins/wk to 450 mins/wk, with continuous lifestyle monitoring.

Minimum of 2 weeks

3 to 7 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Treadmill Walking

Trial Overview

The study tests different levels of pre-surgical aerobic exercise (treadmill walking) on patients with solid tumors. It aims to determine the safest exercise dose and its effects on patient health and cancer outcomes using apps and devices for continuous monitoring.

How Is the Trial Designed?

Group I: Pilot "Proof-of-Concept" Experimental Treatment 1 Intervention

Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear (breast, prostate, and endometrial) or non-linear (lung) dosing schedule for a minimum of 2 weeks.

Group II: Phase 1a: Dose-Finding / Escalation Experimental Treatment 1 Intervention

Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 90 mins/wk to 450 mins/wk delivered over 3 to 7 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Published Research Related to This Trial

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]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

Preoperative exercise interventions, particularly those combining aerobic, strength, and inspiratory muscle training, significantly improve functional outcomes in patients with non-small-cell lung cancer (NSCLC), including walking endurance and peak exercise capacity, based on a meta-analysis of 10 randomized controlled trials involving 676 participants.

These exercise protocols also reduce the risk of hospitalization and postoperative pulmonary complications, suggesting that prehabilitation can enhance recovery and overall medical care for NSCLC patients undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer. Rosero, ID., Ramírez-Vélez, R., Lucia, A., et al.[2020]

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

Postoperative exercise interventions for surgical lung cancer patients have high to moderate-quality evidence showing they can significantly improve exercise capacity and muscle strength, which are crucial for recovery.

Preoperative exercise interventions may also enhance exercise capacity and pulmonary function, reduce the risk of postoperative complications, and shorten hospital stays, although the evidence quality is lower.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise interventions on lung cancer patients: An overview of systematic reviews. Zhou, W., Woo, S., Larson, JL.[2021]

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).

While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]

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