Effectiveness of an Aerobic Exercise Program in Cancer Survivors.

Not Applicable

Not yet recruiting

• Conditions: Aerobic Exercise

• Registration Number: NCT06254989
• Lead Sponsor: Holy Name Medical Center, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study Start: 2024-02-12
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-02-28
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of providing a structured in-person aerobic exercise intervention	6 months	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.

Secondary Outcome Measures

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