The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on the role of obesity in cancer. These studies are examining specialized diet, novel wound treatment techniques, anti-inflammatories, and specific pharmokinetic approaches. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Study Title: A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
Study Type: Pilot/interventional/single-group assignment
Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute
Purpose: To study whether the protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors can help achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life
Primary Outcome Measures: Mean weight loss assessed with the digital scale [time frame: baseline up to 6 months; baseline up to 12 months]
Principal Investigator: Kimberly Resnick, MD, Case Comprehensive Cancer Center; (216) 778-5899, kresnick@metrohealth.org
ClinicalTrials.gov Identifier: NCT02135562
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Study Title: Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Masonic Cancer Center, University of Minnesota
Purpose: To test whether the use of a new wound-closure technique can decrease the rates of wound complications in obese patients with cancer
Primary Outcome Measures: Rate of wound complications (wound dehiscence or infection) [time frame: 1 month after surgery]
Principal Investigator: Deanna G. Teoh, MD, University of Minnesota Clinical and Translational Science Institute; contact Matthew Gerber, (612) 624-9486, mhgerber@umn.edu
ClinicalTrials.gov Identifier: NCT02309944
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Study Title: Nanoemulsion Curcumin for Obesity, Inflammation, and Breast Cancer Prevention—A Pilot Trial
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: The Ohio State University Comprehensive Cancer Center
Purpose: To study a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer
Primary Outcome Measures: Determine the adherence, tolerability, and safety of two doses of nanoemulsion curcumin in women at high risk for developing breast cancer [time frame: Up to 3 months]
Principal Investigator: Lisa Yee, MD, The Ohio State University Comprehensive Cancer Center; (614) 293-6654, lisa.yee@osumc.edu
ClinicalTrials.gov Identifier: NCT01975363
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Study Title: Pancreatic Nutritional Program: A Novel Weight-Reduction Program in Overweight/Obese Breast Cancer Survivors
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: City of Hope Medical Center, National Cancer Institute
Purpose: To study a pancreatic nutritional program for helping patients with stages I–III breast cancer who are overweight or obese lose weight. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
Primary Outcome Measures:
Change in body weight [time frame: baseline to 6 months]
Principal Investigator: Joanne Mortimer, MD, City of Hope Medical Center; (800) 826-4673
ClinicalTrials.gov Identifier: NCT02432950
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Study Title: Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: Fox Chase Cancer Center
Purpose: Having an elevated insulin level in the blood is associated with a shorter median time to prostate cancer progression and median overall survival in patients with an elevated prostate-specific antigen (PSA) after prior treatment. This study evaluates how metformin in combination with bicalutamide (an androgen-deprivation therapy) affects prostate cancer.
Primary Outcome Measures: Biochemical response rate based on PSA [time frame: 32 weeks]
Principal Investigator: Marijo Bilusic, MD, PhD, Fox Chase Cancer Center; (215) 728-3889, marijo.bilusic@fccc.edu
ClinicalTrials.gov Identifier: NCT02614859
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Study Title: Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Study Type: Phase IV/interventional/single-group assignment
Study Sponsor and Collaborators: Texas Tech University Health Sciences Center, University of Texas
Purpose: To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in patients with breast cancer who are normal weight (body mass index [BMI] < 25 kg/m2), overweight or class I obese (BMI = 25–34.9 kg/m2), or class II–III obese (BMI ≥ 35 kg/m2)
Primary Outcome Measures: Area under the curve for doxorubicin and cyclophosphamide [time frame: 0–72 hours]
Principal Investigator: Ronald G. Hall, PharmD, Texas Tech University HSC; contact Vanessa Tagoe, MA, (214) 648-4180, vanessa.tagoe@utsouthwestern.edu
ClinicalTrials.gov Identifier: NCT01537029 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
