Clinical trial NCT06254989: Effectiveness of an Aerobic Exercise Program in Cancer Survivors.
Official title: Effectiveness of a Structured Aerobic Exercise Program in Cancer Survivors - A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aerobic Exercise
Keywords: Exercise
Cancer
Survivorship
Lead sponsor: Holy Name Medical Center, Inc.
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

* Adult (\&gt;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.

Primary outcomes:
measure: Feasibility of providing a structured in-person aerobic exercise intervention
timeFrame: 6 months
Secondary outcomes:
measure: Weight in Lbs
timeFrame: 6 months
measure: Blood Pressure in mmHg
timeFrame: 6 months
measure: Heart Rate in bpm
timeFrame: 6 months
measure: Body Mass Index (BMI) in Kg/m2
timeFrame: 6 months
measure: Predicted VO2 max in ml/kg/min
timeFrame: 6 months
measure: Percentage lean body mass
timeFrame: 6 months
measure: Percentage visceral fat
timeFrame: 6 months
measure: Percentage total body fat
timeFrame: 6 months
measure: Hip circumference measurement in cm
timeFrame: 6 months
measure: Waist circumference measurement in cm
timeFrame: 6 months
measure: Neck circumference measurements in cm
timeFrame: 6 months
measure: Laboratory Assessments of Nutrition, Glucose control and cardiovascular health
timeFrame: 6 months
measure: Average daily step count
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Holy Name Medical Center
name: George Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: