Improving Energy Balance in Men With Prostate Cancer

NCT01886677 | Completed

• 1 other identifier: R21CA161263-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; intervention; diet; physical activity; exercise; weight loss; biomarkers; cancer progression

Outcome Measures

Primary Outcomes (1)

• Tumor Proliferation Rate (Ki-67)

  Changes in tumor proliferation rate (Ki-67) 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.

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

Secondary Outcomes (1)

• Changes in body weight and composition, energy intake and physical activity

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

Study Arms (2)

Immediate diet and exercise intervention

EXPERIMENTAL

A healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week

Behavioral: Immediate diet and exercise intervention

Delayed diet and exercise intervention

OTHER

This arm will receive the same diet and exercise intervention as the experimental arm once recovery from prostatectomy is achieved.

Behavioral: Delayed diet and exercise intervention

Interventions

Immediate diet and exercise intervention BEHAVIORAL

Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).

Immediate diet and exercise intervention

Delayed diet and exercise intervention BEHAVIORAL

Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).

Delayed diet and exercise intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

• 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.

  PMID: 28114897 RESULT

• 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.

  PMID: 33789551 DERIVED

• 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.

  PMID: 29546247 DERIVED

• 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.

  PMID: 27988219 DERIVED

• 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.

  PMID: 26850040 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity; Weight Loss; Disease Progression

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Wendy Demark-Wahnefried, PhD, RD

  University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Webb Endowed Chair of Nutrition Sciences Associate Director, UAB Comprehensive Cancer Center

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 26, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2014-12

Locations

US (1)