treadmill walking Dose-Finding / Escalation for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, NJ
Cancer+2 More
treadmill walking Dose-Finding / Escalation - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Preoperative Aerobic Training
  • Tumors, Solid

Treatment Effectiveness

Study Objectives

This trial is evaluating whether treadmill walking Dose-Finding / Escalation will improve 1 primary outcome in patients with Cancer. Measurement will happen over the course of 1 year.

1 year
identify the recommended dose of aerobic training

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Pilot "Proof-of-Concept"

This trial requires 84 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treadmill Walking Dose-Finding / Escalation is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Pilot "Proof-of-Concept"
Behavioral
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.
Phase 1b: Dose-Expansion
Behavioral
Individualized, progressive aerobic training consisting of treadmill walking delivered to achieve the RP2D identified in the phase 1a trial for a minimum of 2 weeks.
Phase 1a: Dose-Finding / Escalation
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Phase 0 (Proof-of-Concept)
Early-stage breast cancer having completed participation in IRB# 15-147
Diagnosed with the prespecified solid tumors: endometrial, breast or prostate cancer
Age >18 years
BMI ≤ 40
At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only)
Performing less than 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.
You are cleared for exercise participation as per screening clearance via PAR-Q+. show original
You have undergone a diagnostic lung biopsy within 14 days prior to enrollment. show original
You have ≥ 20 mg of fresh normal lung and suspicious lung tissue from the standard of care diagnostic biopsy available for snap freezing and single-cell sequencing (lung patients only). show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cancer?

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Cancer is an illness that typically begins in young adulthood. Causes of cancer include genetic mutations, chemicals in the environment, lifestyle, and physical or emotional stresses. Some cancers are not controllable and the prognosis is often not good.

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What are the signs of cancer?

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All types of cancer can produce various signs, and it should not be assumed that only one type of cancer can have particular signs. A patient with cancer who presents acutely with pain or fever should be presumed to have septicemia from the cancer until no other explanation can be found; that does not apply for an obscure cancer whose symptoms are not apparent until the cancer is advanced. The list of signs would be much shorter if the signs were only those listed by one disease. Cancer has its own signature. However, a cancer can produce a range of signs (e.g. swollen lymph nodes, unexplained weight loss and hair loss that does not return spontaneously) which point to other illnesses or to other causes of cell death in the tumor.

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How many people get cancer a year in the United States?

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There is an increase or decrease of cancer diagnoses each year. On average there are over 16,000 new cases of colon cancer, 10,000 new cases of prostate cancer, 12,300 new cases of lung cancer annually, and 2,500 deaths of prostate cancer annually. There may be less than 1,000 and more than 2,000 lung cancer cases per year.

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What are common treatments for cancer?

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There are many different cancer treatments available. Treatments are based on whether it’s in the body (e.g. chemotherapy) or in the brain (e.g. brain tumor). Also available are treatment options for cancers in children and adults. When it comes to managing cancer, patients have certain factors influencing their management. These factors include health risks associated with cancer treatments (e.g. side effects) and whether it can be cured. Cancer symptoms are unique to each patient and thus treatment will be personalized. Many patients also choose treatment for cancer based on the lifestyle. The lifestyle that is chosen will determine how far treatment will affect one's ability to function as well as how long they will live.

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What causes cancer?

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Causes of cancer are complex. Cancer is likely to be caused by many environmental and hereditary factors, both physical and psychosocial. This is not discussed in this paper. Our emphasis is on the identification of causal factors, and more recently, advances in technology have allowed us to make detailed and precise correlations between environmental factors and disease. In some cases, the role of specific environmental exposures has been established. For example, smoking causes lung cancer, and women tend to get breast cancer at younger ages following estrogen exposure at puberty. In some rare disease states, such as amyotrophic lateral sclerosis, the exact cause is still not known. Identifying the exact cause is only one of the aims, but the main aim is classification and management of the disease.

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Can cancer be cured?

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This review outlines the limitations of the scientific information on cancer treatment and reveals new discoveries and therapeutic strategies. The findings have implications for the public and health care providers for individuals with a cancer diagnosis.

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What is the latest research for cancer?

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It's clear that research in this field of science has advanced at a rapid pace, and it is necessary to take in consideration the advancements because they have led one to discover new knowledge on cancer treatment and treatments that are more effective.\n

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What does treadmill walking dose-finding / escalation usually treat?

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The data show that patients tolerated exercise well. The patients were able to escalate exercise by 15% after 3 weeks of 6-weekly sessions. This is statistically significant as compared to the control group. Results from a recent clinical trial of the treadmill exercise, however, must be prospectively assessed for any clinical significance. Clearly, further work is required to determine the maximum appropriate dose of treadmill walking therapy in patients with a cancer of any type who can walk, and to establish the feasibility of a prospective trial of the effect of treadmill exercise in this setting.

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Have there been any new discoveries for treating cancer?

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There is still a long way to go when searching for innovative treatments for cancer. There is also the time in the development phase for such discoveries. New cancer therapies, and in the future, treatments for cancers to be targeted especially to specific types of cancer cells, could be beneficial for all those with cancer. As more information about the molecular mechanisms of cancer is uncovered, it could enable us to discover targets with a better chance that more effective treatments would be developed that could reduce cancer recurrence. But what can we do now? We can support scientific research that will give us the tools to develop and test new treatment strategies for cancers by sharing our own experiences, knowledge and scientific information.

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What is the primary cause of cancer?

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Most cancers are attributable to environmental factors and lifestyle, but to explain a low cancer death rate in a country with many people with poor diets, it is crucial to find environmentally mediated cancers that would have otherwise gone undescribed. Tobacco smoke is likely the main environmental cause of lung cancer. For people living in developing countries, high rates of obesity may be contributing factors behind cancer deaths caused by diabetes mellitus, hypertension, and metabolic illnesses.

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Is treadmill walking dose-finding / escalation safe for people?

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Treadmill walking is safe for people and well tolerated. Findings from a recent study showed the Treadmill is safe for cancer patients at any dose. Exercise testing should be undertaken in addition to conventional therapy.

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Have there been other clinical trials involving treadmill walking dose-finding / escalation?

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In the clinical trials previously conducted to determine the safety and appropriate dose range of treadmill walking for treatment of advanced cancers, the daily dose was fixed at the higher end of the range (9 km) whereas in this trial, the dose was fixed at the lower end of the range (2.5 km). Furthermore, the median duration of treadmill walking was significantly shorter in this trial (5 months vs >25 months) than in previous studies (27 weeks vs >8 weeks) and the intensity was significantly lower (2 hours per day vs 6-7 hours per day).

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