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Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery

RecruitingNAAges 55 Years - anyAllVA Office of Research and Development
NCT05912257 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In this pragmatic clinical trial, the investigators will study older Veterans approaching surgery for gastrointestinal or genitourinary cancer who are at high risk for a marked decline in their physical function. The investigators will test a multi-targeted nutrition regimen high in protein and other key nutrients and including resistance exercise, administered 2-8 weeks prior to surgery and for 24 weeks after discharge from surgery, with the goal of protecting physical function and improving physiologic, metabolic, and patient-centered outcomes. The findings of this study will promote a better intervention to compensate for the high nutritional demands of cancer and its treatment and lead to stronger, more rapid physical recoveries and better quality of life for older adults with moderate to advanced cancer- a group that has rarely been included in long-term nutrition studies. In additi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and Female Veterans * Stage I, II, III cancer of the bladder, colon, kidney, liver, pancreas, stomach, rectum, prostate, endometrium, ovaries, and uterus * Surgery 2-8 weeks from consent * Age \> 55 years * Age-normal renal function * English speaking * Able to record dietary intake or has a proxy who can record dietary intake * Willing and able to be randomized to either intervention group Exclusion Criteria: * Stage IV cancer diagnosis * Glomerular filtration rates (GFR) less than 45 mL/min * Neurological conditions causing functional impairments, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke * Class III-IV congestive heart failure * Refractory cachexia - medical condition that affects ability to increase muscle mass (e.g., cachexia) defined as 10% weight loss in 10 months, 5% weight loss in 6 months or 2% weight loss over any period plus body mass index 20 kg/m2 AND Life expectancy 9 months * Active treatment for another cancer site * Body weight \>450 lbs * Uncontrolled diabetes (HbA1c 9%) * Recent diagnosis of thyroid disease or untreated thyroid disease * Inability to complete physical function assessment * Severe dietary restrictions * On chemotherapy drug Sorafenib
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What it tests

  • Structured perioperative nutrition and exercise
  • Nutrition and Exercise Counseling
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Where

1 site
Durham VA Medical Center, Durham, NC
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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