RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05912257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female Veterans
  2. * Stage II, III cancer of the bladder, colon, kidney, liver, pancreas, stomach or rectum
  3. * Surgery 6 weeks from consent
  4. * Age \> 60 years
  5. * Age-normal renal function
  6. * English speaking
  7. * Able to record dietary intake or has a proxy who can record dietary intake
  8. * Willing and able to be randomized to either intervention group
  1. * Stage I or IV cancer diagnosis
  2. * Glomerular filtration rates (GFR) less than 45 mL/min
  3. * Neurological conditions causing functional impairments, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
  4. * Class III-IV congestive heart failure
  5. * 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
  6. * Active treatment for another cancer site
  7. * Body weight \>450 lbs
  8. * Uncontrolled diabetes (HbA1c 9%)
  9. * Recent diagnosis of thyroid disease or untreated thyroid disease
  10. * Inability to complete physical function assessment
  11. * Severe dietary restrictions
  12. * On chemotherapy drug Sorafenib

Contacts and Locations

Study Contact

Kathryn N Starr, PhD
CONTACT
(919) 286-0411
kathryn.starr@duke.edu

Principal Investigator

Kathryn N. Starr, PhD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

  • Surgery
  • Perioperative Nutrition
  • Older Adults

Additional Relevant MeSH Terms

  • Cancer