RecruitingNot Applicable

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

United States188 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on a nutrition intervention before and after surgery — given my specific cancer diagnosis and planned surgery, does it make sense to prioritize optimizing my nutrition at this stage, or are there other steps that should come first?
2The trial is measuring changes in my ability to walk six minutes as the main outcome — can you explain why physical function like walking distance matters so much after cancer surgery, and what it might mean for my recovery if it declines?
3Since this study is listed as Phase NA, it sounds like it may be more of a behavioral or supportive care study rather than a drug trial — can you help me understand what that means for how well the safety and benefits of this nutrition approach are already established?
4The trial involves a nutrition intervention both before and after surgery — how demanding would it be to follow this kind of program while I'm also managing my cancer treatment, and is that realistic given my current health and schedule?
5Are there standard nutrition or physical rehabilitation programs already available to me outside of this trial that I should consider, or would participating in this study give me access to a level of support I wouldn't otherwise get?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

6-Minute Walk Change

Timeframe: baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit

Trial details

NCT IDNCT05912257

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Kathryn N Starr, PhD

(919) 286-0411 kathryn.starr@duke.edu

View on ClinicalTrials.gov More Cancer trials