- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06945484
PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study (PILOT PERCC)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Varghese, MD, MS, MBA, FACS
- Phone Number: 801-581-5311
- Email: thomas.varghese@hsc.utah.edu
Study Contact Backup
- Name: Cornelia Ulrich, MS, PhD
- Phone Number: 801-213-5716
- Email: neli.ulrich@hci.utah.edu
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- Recruiting
- University of Texas Medical Branch at Galveston
-
Contact:
- Rebecca Geck, MSN/MPH
- Phone Number: 409-266-0496
- Email: raschaef@utmb.edu
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute
-
Contact:
- Cornelia Ulrich, MS, PhD
- Email: neli.ulrich@hci.utah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Precision Exercise Regimen for Cancer Care (PERCC)
Participants will engage in PERCC starting at least two weeks prior to receiving their first neoadjuvant treatment for lung cancer and continuing until two months after receiving surgical treatment.
|
PERCC has exercise modes including 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).
Each participant will complete one supervised, home-based exercise training session per week, delivered through telehealth, that will focus on the resistance exercise prescription.
Other unsupervised exercise training sessions will focus on the aerobic exercise prescription and will be completed individually
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Recruitment and Retention
Time Frame: 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.
|
up to two months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Safety
Time Frame: 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. |
up to two months post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cornelia Ulrich, MS, PhD, Huntsman Cancer Institute/ University of Utah
Publications and helpful links
General Publications
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
- 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.
- Ettinger DS, Wood DE, Aggarwal C, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, Dilling TJ, Dobelbower M, Gettinger S, Govindan R, Gubens MA, Hennon M, Horn L, Lackner RP, Lanuti M, Leal TA, Lin J, Loo BW Jr, Martins RG, Otterson GA, Patel SP, Reckamp KL, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer KW, Yang SC, Gregory K; OCN; Hughes M. NCCN Guidelines Insights: Non-Small Cell Lung Cancer, Version 1.2020. J Natl Compr Canc Netw. 2019 Dec;17(12):1464-1472. doi: 10.6004/jnccn.2019.0059.
- Tchelebi LT, Shen B, Wang M, Potters L, Herman J, Boffa D, Segel JE, Park HS, Zaorsky NG. Nonadherence to Multimodality Cancer Treatment Guidelines in the United States. Adv Radiat Oncol. 2022 Mar 8;7(5):100938. doi: 10.1016/j.adro.2022.100938. eCollection 2022 Sep-Oct.
- Gao SJ, Corso CD, Wang EH, Blasberg JD, Detterbeck FC, Boffa DJ, Decker RH, Kim AW. Timing of Surgery after Neoadjuvant Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Feb;12(2):314-322. doi: 10.1016/j.jtho.2016.09.122. Epub 2016 Oct 5.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCI162865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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