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

Recruiting now · Not applicable

Conditions studied: Cancer

In brief

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 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.

Key facts

Study ID

NCT05912257

Run by

VA Office of Research and Development

People needed

188

Starts

2024-05-01

Expected to finish

2027-06-30

Last updated by the study team

2026-05-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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