Precise Exercise Regimen for Cancer Care: a small pilot in stage II/III NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility pilot assesses whether the Precise Exercise Regimen for Cancer Care (PERCC) can be implemented for patients with stage II–III NSCLC who are about to start neoadjuvant therapy followed by surgery. Eligible participants undergo baseline fitness assessments, surveys, and study visits over roughly 24 weeks. The study aims to determine practicality, adherence, and data collection processes for a larger trial. About 20 participants are planned to enroll at Dana-Farber Cancer Institute in Boston. English or Spanish speakers who can consent and travel to the site are included; severely underweight or morbidly obese individuals are excluded, as are those with unstable comorbidities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years at time of diagnosis; due to the rarity of the disease in those \<18 years, this age bracket will not be included.
* Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.
* Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.
* Ability to follow directions and complete questionnaires in English and/or Spanish.
* Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
* Willing to travel to DFCI for necessary data collection.

Exclusion Criteria:

* Patients who are morbidly obese (BMI\>40 kg/m2) or Anorexic (BMI\<17 kg/m2).
* Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.
* Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).
* Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.
* Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, PhD, MPH
• Email: christinam_dieli-conwright@dfci.harvard.edu
• Phone: 617-582-8321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.