Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-29 @ 11:32 AM
Study NCT ID:
NCT05912257
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2023-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOSH
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: