Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
NOSH
1 other identifier
interventional
188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started May 2024
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 20, 2026
May 1, 2026
3.2 years
May 30, 2023
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-Minute Walk Change
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 Outcomes (2)
Health-related QoL (QLQ-C30)
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)
baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Study Arms (2)
NOSH
EXPERIMENTALMulti-Targeted NOSH + Exercise (NOSH Regimen) Arm
Typical Regimen
ACTIVE COMPARATORTypical Regimen Arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn N. Starr, PhD
Durham VA Medical Center, Durham, NC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 22, 2023
Study Start
May 1, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share