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EXCAP©® for 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

Study Summary

This trial will test whether a supplement and exercise regimen can help improve or prevent cachexia, a wasting syndrome often seen in cancer patients.

Eligible Conditions

Cancer Cachexia
Gastrointestinal Cancer
Lung 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherance

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

Recruitment and Retention

Secondary outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Smartfish ASIndustry Sponsor

5 Previous Clinical Trials

241 Total Patients Enrolled

University of RochesterLead Sponsor

836 Previous Clinical Trials

518,068 Total Patients Enrolled

Richard Dunne5.01 ReviewsPrincipal Investigator - University of Rochester Wilmot Cancer Center

University of Rochester

3 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this experimental trial?

"The details on clinicaltrials.gov suggest that enrollment for this trial has ended; it was originally posted in April of 2020 and last updated in June of 2022. Despite the closure, there are still 778 other trials actively accepting patients at present."

Answered by AI

To what extent could Remune potentially be hazardous to individuals?

"Due to the lack of clinical data, Remune's safety was given a score of 1 on our ranking system. This is because it is still in Phase 1 trials and has not been sufficiently tested for either efficacy or safety."

Answered by AI

What is the purpose of this trial?

"The primary endpoint of this three month study is the number of participants who adhere to its dietary conditions. Secondary objectives include evaluating a subject's power through the Stair Climb Performance Test, tracking cachexia-related symptoms with the Functional Assessment of Anoreix/Cachexia Therapy subscale and measuring physical function by way of 6 minute walk test distance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Richard Dunne 2020. "Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04131426.