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Arm 1: Investigational INF for Peripheral Neuropathy

N/A
Waitlist Available
Led By Gayathri Nagaraj, MD
Research Sponsored by Loma Linda University
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 upto 3 months post completion of assigned treatment
Awards & highlights

Summary

This trial is testing whether a physical therapy technique called intraneural facilitation (INF) can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of chemotherapy that can cause numbness, pain, and problems with movement and balance.

Eligible Conditions
  • Chemotherapy-induced Peripheral Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 3 months post completion of assigned treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 3 months post completion of assigned treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on CTCAE grading
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on MSNI scores
+1 more
Secondary outcome measures
Measure the peak systolic velocity on ultrasound imaging in the popliteal and posterior tibia artery in the two arms.
Measure the rate of dose reductions in chemotherapy due to peripheral neuropathy by treatment group
Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Standardized muscle stretching and strengthenExperimental Treatment1 Intervention
subjects will receive a standardized program of muscle stretching and strengthening exercise twice a week for six weeks under the supervision of treating physical therapist
Group II: Arm 1: Investigational INFExperimental Treatment1 Intervention
Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow.

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Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
308 Previous Clinical Trials
261,076 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
Gayathri Nagaraj, MDPrincipal Investigator - Loma Linda University Medical Center
Loma Linda University
1 Previous Clinical Trials
Ellen D'Errico, PHDPrincipal InvestigatorLoma Linda University School of Nursing
~6 spots leftby Jul 2025
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