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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how different amounts of aerobic exercise affect how much chemotherapy people receive compared with the planned amount. Aerobic exercise makes your heart beat faster. The study is for adults with stage II or III colon cancer who have had surgery and plan to start chemotherapy.

To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older and have stage II or III colon cancer confirmed by a tissue test.
  • Have had surgery to remove the cancer with the goal of curing it, and plan to start chemotherapy.
  • Do less than 60 minutes a week of planned aerobic exercise at a moderate or hard effort.
  • Have no major surgery planned during the study.
  • Are ready to exercise based on a health questionnaire and can walk 400 meters.
  • Can read and speak English and give written consent to join.
  • Have written approval from a qualified healthcare professional.
  • Are willing to be assigned to a study group by chance.

Who can't join

  • Have signs that colon cancer has spread to other parts of the body.
  • Are also getting active treatment for another type of cancer.
  • Are pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks.
  • Are in another study whose results could conflict with this study.
  • Have another condition or situation that the study doctor thinks would make joining unsafe or prevent you from following the study plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥18 years * Histologically confirmed stage II or III colon cancer * Completed surgical resection with curative intent * Plan to initiate chemotherapy * Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise * No planned major surgery during the study period * Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire * Can walk 400 meters * Can read and speak English * Ability to provide written informed consent * Provide written approval by qualified healthcare professional * Willing to be randomized Exclusion Criteria: * Evidence of metastatic colon cancer * Concurrently actively treated other (non-colon) cancer * Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks * Currently participating in another study with competing outcomes * Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol * Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Study sites (3)

CA

FL

MA