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

NCT05912257 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-05-20

No results posted yet for this study

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 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.

Conditions

Interventions

BEHAVIORAL

Structured 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 for 2-8 weeks prior to their scheduled surgery. 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.

BEHAVIORAL

Nutrition 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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Kathryn N. Starr, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912257 on ClinicalTrials.gov