Clinical trial NCT05912257: Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
Official title: Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Surgery
Perioperative Nutrition
Older Adults
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-06-22
Enrollment: 188
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Detailed description: The overall objective of this study is to administer the nutrition optimization of senior health (NOSH) intervention in biphasic intervals and compare it to a typically recommended nutrition regimen (Typical Regimen) for (1) physical function, (2) physiologic and metabolic outcomes; and (3) Veteran-centered outcomes. The central hypothesis is that NOSH will improve physical function. The investigators also predict improvements in physiologic, metabolic and Veteran-centered outcomes. The investigators seek an optimal intervention to alleviate symptom burden and improve function, health, and QoL for older cancer survivors, and the long-term goal is to confirm and implement this intervention. The primary aim is to evaluate the efficacy of a multi-targeted NOSH intervention on physical function. Based on preliminary data, the investigators' working hypothesis is that the NOSH intervention will result in improved physical function before surgery and after surgery relative to the (Typical Regimen).

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

Primary outcomes:
measure: 6-Minute Walk Change
timeFrame: baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Secondary outcomes:
measure: Health-related QoL (QLQ-C30)
timeFrame: baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
measure: Patient Generated-Subjective Global Assessment (PG-SGA)
timeFrame: baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kathryn N. Starr, PhD
role: PRINCIPAL_INVESTIGATOR
References: