Effectiveness of an Aerobic Exercise Program in Cancer Survivors. (ESAP-CS)

Effectiveness of a Structured Aerobic Exercise Program in Cancer Survivors - A Pilot Study

A prospective study of cancer survivor patients enrolling in a pilot aerobic exercise program. The total enrollment will be fifteen patients. The study timeline includes a screening period of 4 weeks, baseline period of 2 weeks, and active study intervention for 12 weeks. Study enrollment will continue until all 15 subjects are enrolled or up to 12 months, whichever comes first.

Study Overview

• Status: Not yet recruiting
• Conditions: Aerobic Exercise
• Intervention / Treatment: Other: Aerobic Exercise

Detailed Description

Study Population: Adult cancer survivors within one year of completing cancer-directed therapy.

Study Objective: To determine the feasibility of a prescription exercise program in a cancer survivor population

Specific Objectives:

1. Quantify the number of patients who successfully enroll and complete the Program.
2. Determine a preliminary benefit, if any, of the program with regard to biometric parameters (change in systolic blood pressure, BMI, body composition, average step count, VO2 max), laboratory parameters (Hgb A1c, CRP, Lipid Profile, IL-6, Apolipoprotein B, Vitamin D-25-OH, Vitamin B12 and Folate), patient-reported wellness surveys (SEE, SRQ, Sleep Surveys).

Study Endpoints/Outcomes:

A. Percentage of participants who complete the Program. B. Change in systolic blood pressure C. Change in BMI D. Change in body composition E. Change in Average daily step count F. Change in predicted VO2 max F. Change in participant-reported wellness surveys (SEE, SRQ, and Sleep Surveys) G. Change in Circumference measurements (hip, waist, and neck) H. Improvement in laboratory parameters (Hgb A1c, CRP, Lipid profile, IL-6, Alipoprotein B, Vitamin D-25-OH, Vitamin B12, Folate) I. Cancer recurrence

Sample Size: Fifteen subjects

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Miller, MD; Phone Number: 2015307934; Email: Gemiller@holyname.org
• Study Contact Backup: Name: Dan Rector, RN; Phone Number: 4742 2018334742; Email: drector@holyname.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult (>18 yr.) cancer survivor patients who completed treatment within the past year and are able to physically participate in the interventional aerobic exercise program.

Exclusion Criteria:

• Non-ambulatory individuals
• Inability to communicate in English
• Lack of transportation to/from appointments (Of note, language and transportation exclusion criteria are based on practical needs for this pilot study. If effective, services would be open to a broader array of patients).
• On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
• Patients who received cancer-directed therapy within the past month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of providing a structured in-person aerobic exercise intervention	To determine the feasibility of providing a structured in-person aerobic exercise training intervention to cancer survivor patients by determining the percentage of enrolled patients who complete the study.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in Lbs	Change in weight (Lbs) from baseline	6 months
Blood Pressure in mmHg	Change in blood pressure (mmHg) from baseline	6 months
Heart Rate in bpm	Change in Heart rate (bpm) from baseline	6 months
Body Mass Index (BMI) in Kg/m2	Change in BMI from baseline. BMI will be calculated as weight (kg)/height (m2).	6 months
Predicted VO2 max in ml/kg/min	Change in predicted VO2 max from baseline calculated as the milliliters of Oxygen used per kg of body weight per minute	6 months
Percentage lean body mass	Change in lean body mass percentage from baseline	6 months
Percentage visceral fat	Change in visceral fat percentage from baseline	6 months
Percentage total body fat	Change in total body fat percentage from baseline	6 months
Hip circumference measurement in cm	Change in hip circumference measurements from baseline	6 months
Waist circumference measurement in cm	Change in waist circumference measurements from baseline	6 months
Neck circumference measurements in cm	Change in Neck circumference measurements from baseline	6 months
Laboratory Assessments of Nutrition, Glucose control and cardiovascular health	Change in laboratory Assessments of Nutrition, Glucose control and cardiovascular health	6 months
Average daily step count	Change in average daily step count from baseline	6 months

Collaborators and Investigators

• Sponsor: Holy Name Medical Center, Inc.
• Investigators: Principal Investigator: George Miller, MD, Holy Name Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Survivorship
• Other Study ID Numbers: 24-01-HN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No