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

Medical University of South Carolina (MUSC)

Status: Withdrawn

Conditions: Prostate Cancer

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03459755

102805

Pro00071004 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity

Usual care

No Intervention group

Description:

Patients will complete questionnaires and have research blood drawn.