NCT05912257 Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
| NCT ID | NCT05912257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2024-05-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Kathryn N. Starr, PhD
PRINCIPAL INVESTIGATOR
Durham VA Medical Center, Durham, NC
Frequently Asked Questions
Who can join the NCT05912257 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05912257 currently recruiting?
Yes, NCT05912257 is actively recruiting participants. Contact the research team at kathryn.starr@duke.edu for enrollment information.
Where is the NCT05912257 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05912257 clinical trial?
NCT05912257 is sponsored by VA Office of Research and Development. The principal investigator is Kathryn N. Starr, PhD at Durham VA Medical Center, Durham, NC. The trial plans to enroll 188 participants.
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