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Search / Trial NCT05912257

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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 12, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Surgery Perioperative Nutrition Older Adults

ClinConnect Summary

This clinical trial is studying how a special nutrition program can help older Veterans with certain types of cancer maintain their physical strength before and after surgery. The trial focuses on Veterans who are 60 years or older and have stage II or III cancer of the bladder, colon, kidney, liver, pancreas, stomach, or rectum. Participants will follow a high-protein diet and do resistance exercises for 8 weeks before surgery and for 24 weeks after they leave the hospital. The goal is to see if this approach can help them recover faster, feel better, and improve their overall quality of life.

To be eligible for the study, participants must be able to record what they eat or have someone help them with that, and they should be willing to be assigned randomly to one of the study groups. However, those with certain health issues, like advanced cancer, severe heart problems, or uncontrolled diabetes, cannot participate. If you join the trial, you can expect support in managing your diet and exercise during this critical time, which may lead to a quicker recovery and less strain on the health care system.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Kathryn N. Starr, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported