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

No Placebo-Only Group

Summary

This trial is testing a physical therapy technique called INF, which improves blood flow to nerves damaged by chemotherapy. It targets breast cancer and gynecologic cancer patients who are at risk of developing nerve problems from their treatment. By restoring blood flow, INF aims to reduce symptoms like numbness and pain.

Eligible Conditions

Peripheral Neuropathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 3 months post completion of assigned treatment

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

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

Primary study objectives

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 study objectives

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

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

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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