Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05912257

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

Led by VA Office of Research and Development · Updated on 2025-05-28

188

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 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 addition to providing direct benefits to Veterans, the study may also benefit the VA by decreasing demands on the health care system via hastening the recovery of physical function.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and Female Veterans
  • Stage I, II, III cancer of the bladder, colon, kidney, liver, pancreas, stomach or rectum
  • Surgery 6 weeks from consent
  • Age > 60 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
Not Eligible

You will not qualify if you...

  • 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 defined as significant weight loss with low body mass index and life expectancy under 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

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Research Team

K

Kathryn N Starr, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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