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New treatment option for Cancer
Official title Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
ClinicalTrials.gov ID: NCT05912257
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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
You likely can't join if
- 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%...
- Active treatment for another cancer site
See the full eligibility 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 assigned by chance to either intervention group
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.