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WithdrawnNCT03459755Updated Sep 19, 2024

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

An interventional study of Physical Activity in Prostate Cancer, sponsored by Medical University of South Carolina. Withdrawn at 1 site in United States. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention

Why this study was withdrawn
investigator decision
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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03

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Physical Activity

  • No intervention
    Usual care

    Patients will complete questionnaires and have research blood drawn.

Interventions

  • BehavioralPhysical 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

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

    Time frame: From baseline up to 52 weeks

06

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
07

Registry details

Key details

Study ID
NCT03459755
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Nov 27, 2019
Primary completion
Nov 27, 2019
Completion
Nov 27, 2019
Last update
Sep 19, 2024

Study contacts

David Turner, PhD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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