Evaluating Race Specific AGE Accumulation As a Behavioral Biomarker Prostate Cancer Survivors

NCT ID: NCT03459755

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2019-11-27

Brief Summary

The purpose of this study is to show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor response which may correlate with improved quality of life in PCa survivors. AGEs are produced by the body and are affected by lifestyle, weight and diet.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle Intervention

Patients assigned to the Physical Activity arm will undergo exercise testing protocol and have supervised physical activity interventions while on study. Patients will also complete questionnaires and have research blood drawn.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

Patients will have a baseline assessment by undergoing a maximal exercise testing protocol.

For 12 weeks, patients will participate in an exercise session 3 days per week

The patient will then enter a 12 week "Step Down" program in which the number of sessions is decreased to every week, then every 3 weeks.

After the second 12-week period, the patient will enter a 28-week follow up period of unsupervised exercise.

Usual care

Patients will complete questionnaires and have research blood drawn.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity

Patients will have a baseline assessment by undergoing a maximal exercise testing protocol.

For 12 weeks, patients will participate in an exercise session 3 days per week

The patient will then enter a 12 week "Step Down" program in which the number of sessions is decreased to every week, then every 3 weeks.

After the second 12-week period, the patient will enter a 28-week follow up period of unsupervised exercise.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patient diagnosed with non-metastatic Stage I-III Prostate Cancer

2. Age 45 years and older

3. Within 12 months of first histologic prostate cancer diagnosis.

4. Completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study.

5. BMI > 25

6. ECOG Performance Status 0 or 1.

7. Access to a telephone.

8. Able to read and understand written and spoken English.

9. Participants must be accessible for treatment and follow-up and must sign informed consent.

10. Subjects with known diabetes are permitted. However, they must be under active treatment for this condition.

11. Participants must past the cardiac rehabilitation center stress test.

Exclusion Criteria

1. Planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study

2. Received chemotherapy or radiation therapy within 4 weeks of enrollment

3. Had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion).

4. Previously participated in Cardiac-Rehab

5. Have constrained mobility secondary to problems with balance, bone and/or joint disease

6. Have unstable angina or cardiovascular disease that prohibits exercise.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Turner, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00071004

Identifier Type: OTHER

Identifier Source: secondary_id

102805

Identifier Type: -

Identifier Source: org_study_id