PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study

Not Applicable

Not yet recruiting

• Conditions: NSCLC Stage II; NSCLC, Stage III

• Registration Number: NCT06945484
• Lead Sponsor: University of Utah

Brief Summary

This study is designed to evaluate whether a precision exercise regimen is feasible to implement within cancer populations, specifically stage II-III primary lung cancer patients receiving multimodal therapy, and delivered through telehealth.

Detailed Description

This is a pilot study evaluating the feasibility of the Precision Exercise Regimen for Cancer Care (PERCC) intervention in stage II and stage III Non-Small Cell Lung Cancer (NSCLC) patients receiving multimodal therapy at the Huntsman Cancer Institute (HCI) at the University of Utah. Eligible patients will begin the intervention at the pre-treatment clinic visit and continue until approximately two months post-surgery.

The PERCC intervention is a virtually supervised home-based exercise program. Participants will engage in exercise starting at least two weeks before receiving their first neoadjuvant treatment for lung cancer and continuing until two months after receiving surgical treatment. The exercise modes will include basic transfer and calisthenics mobility, aerobic, and resistance exercises and will be performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Study Start: 2025-05
• Primary Completion: 2026-08
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ages 18 and older at time of diagnosis
• Patient diagnosed with stage II and III non-small cell lung cancer (NSCLC)
• Patient receives either neoadjuvant chemotherapy or immunotherapy and surgery
• Patient able to follow direction and complete questionnaires in English or Spanish
• Patient agrees to complete the PERCC intervention

Exclusion Criteria

• Morbidly obese (BMI >40 kg/m2 ) or anorexic (BMI <17.5 kg/m2 )
• Abnormalities on screening physical exam per study physicians or physical therapist to contraindicate participation in exercise program compliance
• Alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer)
• Patient scheduled to receive single modality cancer treatment (unimodal therapy), scheduled to begin treatment within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility - Recruitment and Retention	up to two months post-surgery	Feasibility of the PERCC intervention will be evaluated by our ability to recruit and retain the needed number of patients with 80% exercise intervention attendance.

Secondary Outcome Measures

Name	Time	Method
Feasibility - Safety	up to two months post-surgery	The feasibility of the PERCC intervention will be evaluated based on participant safety.; This outcome measure will assess the safety and tolerability of the study treatment.; The severity of AEs will be assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE".; Subjects will be monitored for adverse events from the start of treatment until two months post-surgery.

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States