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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

Study 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.Check my eligibility

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.See study design

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

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

Secondary outcome measures

CIPN-20 sensory subscale

Cold-induced pain

Numbness and tingling

+2 more

Other outcome measures

Cardiovascular function

Immunological function

Musculoskeletal function

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,926,013 Total Patients Enrolled

14 Trials studying Peripheral Neuropathy

1,473 Patients Enrolled for Peripheral Neuropathy

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,596 Total Patients Enrolled

Media Library

EXCAP Exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05452902 — N/A

Peripheral Neuropathy Research Study Groups: EXCAP Exercise, Nutrition Education

Peripheral Neuropathy Clinical Trial 2023: EXCAP Exercise Highlights & Side Effects. Trial Name: NCT05452902 — N/A

EXCAP Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452902 — N/A

Frequently Asked Questions

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

Has the FDA cleared EXCAP Exercise for use?

"EXCAP Exercise's Phase 2 status means that, while there is some data supporting safety, there is no efficacy data. Therefore, our team at Power rates EXCAP Exercise as a 2 in terms of safety."

Answered by AI

What is the current enrollment for this research project?

"Yes, the information available on clinicaltrials.gov indicates that this study is actively searching for participants. The trial was first posted on October 25th, 2020 and was last updated on the same date. 60 individuals are needed for the 1 location conducting this research."

Answered by AI