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

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Behavioral: Physical Activity

• Registration Number: NCT03459755
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-09
• Study Start: 2019-11-27
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood	From baseline up to 52 weeks

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States