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Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer

Phase 2
19 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer

This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men
newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will
use the presurgical period to explore the potential impact of weight loss via a healthy
energy-restricted diet and increased physical activity on circulating hormones, cytokines,
and growth factors, as well as effects on tumor biology and other clinical outcomes.
Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet +
exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list
control who will receive the intervention once the study period is complete. Both groups
will receive nutritional counseling during the study period to correct nutritional
deficiencies with food sources. This study will explore and contrast changes in body mass
index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs.
wait-list control arms, and also monitor changes in body composition, 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 immunohistochemical markers of insulin receptor,
vascular endothelial growth factor (VEGF), AKT, and nuclear factor
kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related
outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional

Inclusion Criteria:

- Histopathologically confirmed prostate cancer

- Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation
therapy, etc)

- Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to
participate in the diet and exercise program a full 3.5 weeks).

- Body mass index (BMI) 25 - 49.9

- Mentally competent

- Able to speak and write English

- Has telephone access

- Agrees to be randomized to either study arm (immediate or delayed diet and exercise

Exclusion Criteria:

- Another active malignancy (not including non-melanoma skin cancer)

- Medical conditions that affect weight (e.g., untreated thyroid disturbances

- Currently on a weight loss regimen

- Preexisting medical condition(s) that preclude adherence to unsupervised exercise,
e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone
metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina,
heart attack, congestive heart failure or conditions that dictated hospitalization or
oxygen within 6-mths, etc.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Body Mass Index (BMI)

Outcome Description:

Changes in body mass index (BMI) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms.

Outcome Time Frame:

Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)

Safety Issue:


Principal Investigator

Wendy Demark-Wahnefried, PhD, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham (UAB)


United States: Institutional Review Board

Study ID:




Start Date:

September 2012

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • intervention
  • diet
  • physical activity
  • exercise
  • weight loss
  • biomarkers
  • cancer progression
  • Prostatic Neoplasms



University of Alabama at Birmingham (UAB) Birmingham, Alabama  35233