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

May 18, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Recruiting
        • Durham VA Medical Center, Durham, NC
        • Principal Investigator:
          • Kathryn N. Starr, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Typical Regimen
Typical Regimen Arm
Behavioral: Nutrition and Exercise Counseling
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.
Experimental: NOSH
Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm
Behavioral: Structured perioperative nutrition and exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Change
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.
baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related QoL (QLQ-C30)
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.
baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Patient Generated-Subjective Global Assessment (PG-SGA)
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.
baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F3981-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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