Effectiveness of an Aerobic Exercise Program in Cancer Survivors.

NCT ID: NCT06254989

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2025-06-30

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

Conditions

Aerobic Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Aerobic Exercise

Participants will engage in aerobic exercise at HNH fitness at a minimum of 2 days a week for 12 weeks. Participants will have their daily step count collected via the Fitbit during this period. VO2 measurements will also be collected during active intervention using the UNCCRI protocol.

The structured aerobic exercise program (Weeks 3-14) will entail 30 minutes of aerobic activity, 3 days a week, on the treadmill, at a goal of between 50 to 70% of predicted VO2 maximum heart rate. All structured aerobic program sessions will take place at Holy Name Health (HNH) Fitness and will be overseen by our collaborator and Director of Human Performance (Reg Grant). Exercise data will be recorded in the Technogym MyWellness cloud. Participants who drop out or discontinue attendance (defined as 4 consecutive sessions missed without notification of absence) before completion of the 12-week study intervention period will be replaced.

Intervention Type: OTHER

Eligibility Criteria

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
• On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
• Patients who received cancer-directed therapy within the past month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holy Name Medical Center, Inc.

OTHER

Sponsor Role: lead

Responsible Party

George Miller

Chief of Surgical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Holy Name Medical Center

Central Contacts

George Miller, MD

Role: CONTACT

Gemiller@holyname.org

2015307934

Dan Rector, RN

Role: CONTACT

drector@holyname.org

2018334742 ext. 4742

Other Identifiers

24-01-HN

Identifier Type: -

Identifier Source: org_study_id