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Chemotherapy

Ultrasound for Detecting Chemotherapy-Induced Peripheral Neuropathy

N/A
Recruiting
Led By Roy Strowd, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gastrointestinal cancer
Colorectal cancer (any stage)
Must not have
Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at using ultrasound to detect neuropathy in gastrointestinal cancer patients caused by the chemotherapy drug oxaliplatin.

Who is the study for?
This trial is for patients with any stage of gastrointestinal or colorectal cancer who are currently or have previously been treated with oxaliplatin-based chemotherapy and now show signs of peripheral neuropathy. Participants must be able to understand and sign a consent form.
What is being tested?
The study is testing the effectiveness of ultrasound in detecting neuropathy caused by oxaliplatin in gastrointestinal cancer patients. It involves nerve exams, skin biopsies, nerve conduction studies, blood draws, and questionnaires about chemotherapy-induced peripheral neuropathy.
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound procedure on nerves, minor pain or bruising from skin biopsies and blood draws, as well as possible emotional distress from discussing symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have cancer in my digestive system.
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I have been diagnosed with colorectal cancer.
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I am currently or have previously been treated with oxaliplatin-based chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had nerve damage in my hands or feet before starting oxaliplatin chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tibial Nerve Cross-Sectional Area Comparison
Secondary study objectives
Amplitude of Nerve Response of Sural Nerve
Amplitude of Nerve Response of Tibial Nerve
Conduction Velocity of Nerve Response of Sural Nerve
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: UltrasoundExperimental Treatment6 Interventions
Undergo peripheral nerve ultrasound
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin Biopsy
2015
Completed Phase 4
~680
Nerve Conduction Study
2009
N/A
~170

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,452,835 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,433 Total Patients Enrolled
Roy Strowd, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
114 Total Patients Enrolled
~1 spots leftby Mar 2025
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