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Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia

Phase 1

Waitlist Available

Led By Richard Dunne

Research Sponsored by University of Rochester

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 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special diet supplement and an exercise routine to help patients with lung or gastrointestinal cancers who are losing weight. The supplement aims to provide essential nutrients, while the exercise helps build muscle and improve overall health.

Eligible Conditions

Cancer Cachexia
Obesity
Lung Cancer
Gastrointestinal Cancer
Weight Loss

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherance

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Recruitment and Retention

Secondary study objectives

Porportion of subjects with improved cachexia-related symptoms 3 months

Proportion of subjects that improve physical function- Muscle Strength

Proportion of subjects that improve physical function- Power

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Remune dosed twice daily and daily exercise with EXCAPExperimental Treatment2 Interventions

A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist

Group II: Remune dosed twice dailyExperimental Treatment1 Intervention

A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist

Group III: Usual CareActive Control1 Intervention

Usual standard care as prescribed by your oncologist

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remune

2020

Completed Phase 1

~30