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Exercise and Nutrition Interventions for Chemotherapy-Induced Peripheral Neuropathy

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

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 time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether exercise or nutrition education can help with a side-effect of chemotherapy called CIPN, which causes severe pain and numbness.

Who is the study for?

This trial is for adults over 18 with gastrointestinal cancer who are about to start or have recently started platinum chemotherapy (like oxaliplatin). They must be able to read English and not already doing regular exercise. People can't join if they have physical limitations, planned surgeries, brain-related cancers, or conditions that make MRI scans unsafe.

What is being tested?

The study compares the effects of an exercise program called EXCAP Exercise against Nutrition Education on chemotherapy-induced nerve pain and damage. It's a phase II trial aiming to understand how these interventions might reduce inflammation and improve body sensation.

What are the potential side effects?

Since this trial involves exercise and education rather than drugs, side effects may include typical exercise-related issues like muscle soreness or strain. The nutrition education should not cause direct side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

CIPN-20 sensory subscale

Cold-induced pain

Numbness and tingling

+2 more

Other study objectives

Cardiovascular function

Immunological function

Musculoskeletal function

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EXCAP ExerciseExperimental Treatment1 Intervention

Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.

Group II: Nutrition EducationActive Control1 Intervention

Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EXCAP Exercise

2017

N/A

~30

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