NCT Number: NCT05912257
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.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705-3875, United States
Location status: Recruiting
Josephine C Mcwhorter
CONTACT
(919) 286-0411 ext. 176772
Kathryn N Starr, PhD
CONTACT
Kathryn N. Starr, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutrition counseling by a RD and prescribed a eucaloric diet with protein intake of 1.5 g/kg/d and at least 30 g high quality protein per meal. They will be provided 30 grams of high quality protein twice a day, Hydroxymethylbutyrate, and vitamin D3 and multi-vitamin. Participants will attend nutrition and exercise group classes for 2-8 weeks prior to their scheduled surgery. Following following discharge home, participants will be instructed to resume group classes and protein, HMB, vitamin-D and MVS regimen, and exercise classes will resume when cleared by surgical team.
nutrition counseling by study Registered Dietitian (RD) and prescribed a eucaloric diet with protein intake of 1.0 g/kg/d and a one a day multivitamin/multimineral supplement. They will be counseled on exercising three times per week and given access to exercise videos. Following following discharge home, participants will be instructed to resume protein recommendations and MVS, and exercise recommendations will resume when cleared by surgical team.
Time frame: baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Distance walked in 6 minute.
Time frame: baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
QLQ-C30 is a patient reported outcome measure designed to assess the functional health (physical, role, emotional, social, cognitive), symptom burden (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea), and health-related quality of life of adults with cancer. Raw scores are transformed to a 0-100 scale, with a higher score representing better functioning/quality of life and greater symptom burden.
Time frame: baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
PG-SGA is a hands-on assessment of weight, muscle and fat mass, food intake, and nutrition impact symptoms117 using a global rating nutritional diagnosis (A=well nourished, B = moderate/suspected malnutrition, or C=severely malnourished) and a continuous numerical score (1 to 30 - with higher scores representing greater nutritional risk) for intervention triage. The continuous numerical score allows for comparison of changes in nutritional status over short duration of time.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Acronym: NOSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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