EXCAP Exercise for Peripheral Nervous System Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Maryland Medical System, Baltimore, MD
Peripheral Nervous System Diseases+1 More
EXCAP Exercise - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Eligible Conditions

  • Peripheral Nervous System Diseases
  • Chemotherapy-induced Peripheral Neuropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Peripheral Nervous System Diseases

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Week 24
CIPN-20 sensory subscale
Sensory, motor, and autonomic symptoms of CIPN
Week 12
Cardiovascular function
Cold-induced pain
Immunological function
Musculoskeletal function
Neuropsychological function
Numbness and tingling
Sensory loss

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Peripheral Nervous System Diseases

Trial Design

2 Treatment Groups

Nutrition Education
1 of 2
EXCAP Exercise
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: EXCAP Exercise · No Placebo Group · Phase 2

EXCAP Exercise
Behavioral
Experimental Group · 1 Intervention: EXCAP Exercise · Intervention Types: Behavioral
Nutrition Education
Behavioral
ActiveComparator Group · 1 Intervention: Nutrition Education · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXCAP Exercise
2017
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Trial Background

Prof. Ian Kleckner,, PhD
Principal Investigator
University of Maryland, Baltimore
Closest Location: University of Maryland Medical System · Baltimore, MD
Photo of Baltimore  1Photo of Baltimore  2Photo of Baltimore  3
2000First Recorded Clinical Trial
1 TrialsResearching Peripheral Nervous System Diseases
18 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.