Pre-surgical Aerobic Exercise for Cancer

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Treadmill Walking for cancer patients?

Research shows that preoperative exercise, including aerobic activities like treadmill walking, can improve walking endurance, exercise capacity, and reduce the risk of hospitalization and lung complications in patients undergoing surgery for lung cancer. ^{1 2 3 4 5}

Is pre-surgical aerobic exercise safe for cancer patients?

There is limited information on the safety of exercise for cancer patients, but a protocol called the Exercise Harms Reporting Method (ExHaRM) has been developed to improve the assessment and reporting of any potential harms. This method has been used in various exercise trials for different types of cancer, suggesting a structured approach to monitor safety. ^{6 7 8 9 10}

How does treadmill walking as a pre-surgical treatment for cancer differ from other treatments?

Treadmill walking as a pre-surgical treatment for cancer is unique because it focuses on improving physical fitness and functional capacity before surgery, which may help reduce complications and improve recovery. Unlike traditional cancer treatments that target the disease directly, this approach aims to enhance the body's resilience and overall health through aerobic exercise. ^{1 2 11 12 13}

What is the purpose of this trial?

The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices. Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise and will continue evaluating the quality of at-home study procedures, which includes the use of continuous lifestyle monitoring through apps and electronic devices. In order to facilitate completion of the phase 1a component, we will backfill the 90, 225, and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.

Research Team

Lee W. Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. [2022]

2. Switzerland 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. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

Preoperative physical activity is associated with prognosis in patients with esophageal cancer undergoing thoracoscopic-laparoscopic esophagectomy after neoadjuvant chemotherapy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Association between physical activity and the time course of cancer recurrence in stage III colon cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise interventions on lung cancer patients: An overview of systematic reviews. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Designing, analyzing, and interpreting observational studies of physical activity and cancer outcomes from a clinical oncology perspective. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Cancer Treatment Efficacy: A Systematic Review of Preclinical and Clinical Studies. [2023]

11. United States 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: a randomized controlled pilot study. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects and potential mechanisms of exercise training on cancer progression: a translational perspective. [2021]