Nutrition and exercise intervention for older cancer patients before and after surgery
Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery
This study tests if a special nutrition and exercise program can help older Veterans with gastrointestinal or genitourinary cancer recover better after surgery compared to a regular nutrition plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05912257 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a multi-targeted nutrition regimen and resistance exercise on older Veterans undergoing surgery for gastrointestinal or genitourinary cancer. The intervention, known as the nutrition optimization of senior health (NOSH), is administered for eight weeks prior to surgery and continues for 24 weeks post-surgery. The study aims to compare the NOSH intervention with a typical nutrition regimen to evaluate its impact on physical function, metabolic outcomes, and overall quality of life. The goal is to enhance recovery and reduce the decline in physical function often seen in older cancer patients.
Who should consider this trial
Good fit: Ideal candidates are male and female Veterans aged over 60 with stage I, II, or III cancer of specific organs who are scheduled for surgery within six weeks.
Not a fit: Patients with stage IV cancer, severe renal impairment, or significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve recovery and quality of life for older adults with cancer.
How similar studies have performed: While similar approaches have been explored, this specific intervention targeting older cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and Female Veterans * Stage I, II, III cancer of the bladder, colon, kidney, liver, pancreas, stomach or rectum * Surgery 6 weeks from consent * Age \> 60 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
Where this trial is running
Durham, North Carolina
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn N. Starr, PhD — Durham VA Medical Center, Durham, NC
- Study coordinator: Kathryn N Starr, PhD
- Email: kathryn.starr@duke.edu
- Phone: (919) 286-0411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.