Recruiting

Nutrition Intervention

Sponsor:

VA Office of Research and Development

Code:

NCT05912257

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Structured perioperative nutrition and exercise

Nutrition and Exercise Counseling

Study Details

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 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.

Conditions

Cancer

Study ID

NCT05912257

Start date

May 1, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: NOSH

Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm

active comparator: Typical Regimen

Typical Regimen Arm

Interventions

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kathryn N Starr, PhD

(919) 286-0411kathryn.starr@duke.edu

Josephine C Mcwhorter

(919) 286-0411josephine.mcwhorter@va.gov

Locations

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Kathryn N Starr, PhD

919-286-0411kathryn.starr@duke.edu

Josephine C Mcwhorter

(919) 286-0411josephine.mcwhorter@va.gov

Principal Investigator:

Kathryn N. Starr, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • Surgery
  • Perioperative Nutrition
  • Older Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-20.