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

Prostate Cancer Clinical Trial

Official title:

Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker That Can Reflect Optimal Health in Prostate Cancer Survivors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03459755
• Other study ID #: 102805
• Secondary ID: Pro00071004
• Status: Withdrawn
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: November 27, 2019

Study information

• Verified date: December 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.		From baseline to up to 52 weeks
Primary	Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire.		From baseline to up to 52 weeks
Secondary	Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood		From baseline up to 52 weeks