Clinical trial · Interventional
Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutrition and Exercise Counseling | Behavioral | — | UNRESOLVED |
| Structured perioperative nutrition and exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NOSH
- description
- Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm
- interventionNames
- Behavioral: Structured perioperative nutrition and exercise
- type
- ACTIVE_COMPARATOR
- label
- Typical Regimen
- description
- Typical Regimen Arm
- interventionNames
- Behavioral: Nutrition and Exercise Counseling
Primary outcomes (1)
- measure
- 6-Minute Walk Change
- timeFrame
- baseline, within 72 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available