RecruitingNot ApplicableNCT05912257

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

Sponsor

VA Office of Research and Development

Enrollment

188 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cancer

Summary

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.

Eligibility

Min Age: 60 Years

Inclusion Criteria8

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

Exclusion Criteria12

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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Interventions

BEHAVIORALStructured perioperative nutrition and exercise

Nutrition counseling by a RD and prescribed a eucaloric diet with protein intake of 1.5 g/kg/d and at least 30 g high quality protein per meal. They will be provided 30 grams of high quality protein twice a day, Hydroxymethylbutyrate, and vitamin D3 and multi-vitamin. Participants will attend nutrition and exercise group classes 6-8 weeks. Following following discharge home, participants will be instructed to resume group classes and protein, HMB, vitamin-D and MVS regimen, and exercise classes will resume when cleared by surgical team.

BEHAVIORALNutrition and Exercise Counseling

nutrition counseling by study Registered Dietitian (RD) and prescribed a eucaloric diet with protein intake of 1.0 g/kg/d and a one a day multivitamin/multimineral supplement. They will be counseled on exercising three times per week and given access to exercise videos. Following following discharge home, participants will be instructed to resume protein recommendations and MVS, and exercise recommendations will resume when cleared by surgical team.