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The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial

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

  • Procedures mentioned: Blood draws, Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires."
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 whether an exercise and nutrition program before surgery is practical for people with rectal cancer. It compares the program with usual care in adults getting chemotherapy, radiation, or both before surgery.

The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

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

Eligibility

Who can join

  • You are age 18 or older.
  • You speak English.
  • You have stage II or III rectal cancer.
  • You plan to start, are getting, or just finished chemotherapy, radiation with chemotherapy, or a full course of these treatments before planned surgery to remove the cancer.
  • You can understand the study steps, agree to follow the program, and freely give consent to join.

Who can't join

  • Your cancer was known to have spread to distant parts of the body when you were diagnosed.
  • You cannot do the exercise tests.
  • You have a health condition or a problem with thinking or movement that makes exercise unsafe.
  • You are also being treated for a separate cancer.
  • You are in another clinical trial that would keep you from doing this study’s tasks.
  • Over the past month, you have been doing more than 60 minutes per week of aerobic exercise that makes you breathe moderately hard or very hard.

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

Official eligibility criteria

Inclusion Criteria: * Age greater than or equal to 18 years at time of enrollment. * English-Speaking. * Diagnosis of clinical stage II-III rectal cancer. * Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow. * Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent. Exclusion Criteria: * Distant metastatic disease known at the time of diagnosis. * Functional incapacity (i.e., incapable of performing exercise testing). * Comorbid conditions or cognitive/physical impairments that contraindicate exercise. * Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer. * Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial. * Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.

Study sites (2)

MA