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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Intervention

Usual care

Arm 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.

Patients will complete questionnaires and have research blood drawn.

Outcomes

Primary Outcome Measures

Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.
Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire.

Secondary Outcome Measures

Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood

Full Information

First Posted
February 27, 2018
Last Updated
December 2, 2019
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03459755
Brief Title
Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker Prostate Cancer Survivors
Official Title
Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker That Can Reflect Optimal Health in Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
investigator decision
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients will complete questionnaires and have research blood drawn.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.
Time Frame
From baseline to up to 52 weeks
Title
Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire.
Time Frame
From baseline to up to 52 weeks
Secondary Outcome Measure Information:
Title
Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood
Time Frame
From baseline up to 52 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient diagnosed with non-metastatic Stage I-III Prostate Cancer Age 45 years and older Within 12 months of first histologic prostate cancer diagnosis. Completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study. BMI > 25 ECOG Performance Status 0 or 1. Access to a telephone. Able to read and understand written and spoken English. Participants must be accessible for treatment and follow-up and must sign informed consent. Subjects with known diabetes are permitted. However, they must be under active treatment for this condition. Participants must past the cardiac rehabilitation center stress test. Exclusion Criteria: Planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study Received chemotherapy or radiation therapy within 4 weeks of enrollment Had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion). Previously participated in Cardiac-Rehab Have constrained mobility secondary to problems with balance, bone and/or joint disease Have unstable angina or cardiovascular disease that prohibits exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Turner, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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