Clinical trial NCT06945484: PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study
Official title: PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NSCLC Stage II
NSCLC, Stage III
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Recruitment and Retention
timeFrame: up to two months post-surgery
Secondary outcomes:
measure: Feasibility - Safety
timeFrame: up to two months post-surgery
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
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citation: Hanna TP, King WD, Thibodeau S, Jalink M, Paulin GA, Harvey-Jones E, O'Sullivan DE, Booth CM, Sullivan R, Aggarwal A. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ. 2020 Nov 4;371:m4087. doi: 10.1136/bmj.m4087.
citation: Yalman D. Invited Editorial on "the timing of surgery after neoadjuvant chemoradiation in locally advanced non-small cell lung cancer". J Thorac Dis. 2017 Mar;9(3):E299-E300. doi: 10.21037/jtd.2017.02.98. No abstract available.