Clinical trial NCT01886677: Improving Energy Balance in Men With Prostate Cancer
Official title: Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
intervention
diet
physical activity
exercise
weight loss
biomarkers
cancer progression
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-26
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression.

PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.

Detailed description: 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 status.

Eligibility criteria: 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 program)

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.

Primary outcomes:
measure: Tumor Proliferation Rate (Ki-67)
timeFrame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Secondary outcomes:
measure: Changes in body weight and composition, energy intake and physical activity
timeFrame: Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham (UAB)
name: Wendy Demark-Wahnefried, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Erratum to: Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2017 Jan 23;17(1):71. doi: 10.1186/s12885-016-3025-3. No abstract available.
citation: Smith KS, Fruge AD, van der Pol W, Caston NE, Morrow CD, Demark-Wahnefried W, Carson TL. Gut microbial differences in breast and prostate cancer cases from two randomised controlled trials compared to matched cancer-free controls. Benef Microbes. 2021 Jun 15;12(3):239-248. doi: 10.3920/BM2020.0098. Epub 2021 Apr 1.
citation: Fruge AD, Dasher JA, Bryan D, Rais-Bahrami S, Demark-Wahnefried W, Hunter GR. Physiological Effort in Submaximal Fitness Tests Predicts Weight Loss in Overweight and Obese Men with Prostate Cancer in a Weight Loss Trial. Int J Cancer Clin Res. 2017;4(2):083. doi: 10.23937/2378-3419/1410083. Epub 2017 Oct 16.
citation: Fruge AD, Ptacek T, Tsuruta Y, Morrow CD, Azrad M, Desmond RA, Hunter GR, Rais-Bahrami S, Demark-Wahnefried W. Dietary Changes Impact the Gut Microbe Composition in Overweight and Obese Men with Prostate Cancer Undergoing Radical Prostatectomy. J Acad Nutr Diet. 2018 Apr;118(4):714-723.e1. doi: 10.1016/j.jand.2016.10.017. Epub 2016 Dec 15.
citation: Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2016 Feb 5;16:61. doi: 10.1186/s12885-016-2075-x.