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Behavioral Intervention
Nutrition and Exercise Intervention for Cancer in Older Adults (NOSH Trial)
N/A
Waitlist Available
Led By Kathryn N. Starr, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Awards & highlights
NOSH Trial Summary
This trial will study how nutrition and exercise can help older adults with cancer recover faster and better.
Who is the study for?
This trial is for older Veterans over 60 with Stage II or III cancer of the bladder, colon, kidney, liver, pancreas, stomach or rectum who are English-speaking and can record their diet (or have someone who can). They must be scheduled for surgery in 6 weeks and have normal kidney function. Those with early-stage I or advanced stage IV cancer, severe diabetes, weight over 450 lbs., certain neurological conditions or severe heart failure cannot join.Check my eligibility
What is being tested?
The study tests a nutrition and exercise program before and after surgery for gastrointestinal/genitourinary cancer. Participants will follow a high-protein diet with key nutrients plus resistance exercise starting from 8 weeks pre-surgery to 24 weeks post-discharge. The goal is to preserve physical function and improve recovery outcomes.See study design
What are the potential side effects?
While specific side effects aren't detailed here as it's a nutrition/exercise intervention rather than medication-based treatment; potential risks may include muscle strain from exercise or digestive changes due to new diets.
NOSH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, 24 weeks following post-op visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-Minute Walk Change
Secondary outcome measures
Health-related QoL (QLQ-C30)
Patient Generated-Subjective Global Assessment (PG-SGA)
Short Physical Performance Batter (SPPB) Score
NOSH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NOSHExperimental Treatment1 Intervention
Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm
Group II: Typical RegimenActive Control1 Intervention
Typical Regimen Arm
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,415 Total Patients Enrolled
Kathryn N. Starr, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery is planned within 6 weeks from giving consent.I have lost significant weight recently and my doctors think I have less than 9 months to live.My cancer is diagnosed as either Stage I or Stage IV.My kidney function is reduced with a GFR under 45 mL/min.I am willing and able to follow any treatment plan I am assigned to.I am over 60 years old.I have a neurological condition like Parkinson's, MS, or disability from a stroke.I am a veteran.I cannot complete physical function tests.My cancer is in the bladder, colon, kidney, liver, pancreas, stomach, or rectum and is at Stage II or III.My body weight is over 450 lbs.I am currently taking the chemotherapy drug Sorafenib.My kidney function is normal for my age.My heart condition severely limits my daily activities.I have been recently diagnosed with or have untreated thyroid disease.
Research Study Groups:
This trial has the following groups:- Group 1: Typical Regimen
- Group 2: NOSH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this medical research still ongoing?
"It appears that the clinical trial in question is not currently accepting applicants. The entry was originally posted on August 1st 2023 and recently edited on June 12th of the same year. Although this specific study isn't enrolling, there are 533 other trials presently recruiting participants."
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