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NCT02224807 · ClinicalTrials.gov registry record · NA
Effects of Diet and Exercise on Ductal Carcinoma in Situ
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT02224807 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants.
The verdict
NCT02224807, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary approaches to correct nutritional deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and guidance to correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study will explore and contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in the experimental vs. attention control arms, and also monitor changes in energy intake and physical activity. These changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor tissue and blood will be examined from pre-to-post-intervention, this study will provide exciting new data that can elucidate pathways by which energy balance affects breast cancer progression. Although longer term weight loss is recommended for overweight and obese breast cancer survivors, it is not known whether placing the body in a state of negative energy balance will have a fav
Interventions
- BEHAVIORAL Active Comparator: Progressive Resistance Training (PRT) and a healthy diet
- BEHAVIORAL Experimental: PRT and a healthy diet, plus weight loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-07 |
| Est. Completion | 2018-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02224807
The ClinicalTrials.gov registry entry for NCT02224807 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active Comparator: Progressive Resistance Training (PRT) and a healthy diet is the first listed.
NCT02224807 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02224807 about?
NCT02224807 is a clinical study titled "Effects of Diet and Exercise on Ductal Carcinoma in Situ". This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer (Stage I or II) who elect mastec...
What is the current status of trial NCT02224807?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2014-07. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02224807?
The interventions under investigation include: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet (BEHAVIORAL), Experimental: PRT and a healthy diet, plus weight loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT02224807?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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