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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

Study 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.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,944 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

Frequently Asked Questions

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

To what extent is enrollment for this clinical trial open to participants?

"Affirmative, clinicaltrials.gov's records indicate that this medical experiment is actively enrolling participants. This research was posted on September 28th 2017 and revised for the last time on July 1st 2022. Forty patients are being recruited from a single site."

Answered by AI

What is the purpose of this clinical investigation?

"The primary goal of this medical experiment, which will evaluate the results after 3 months post-treatment completion, is to deploy Descriptive Statistics in order to gauge the level of peripheral neuropathy as indicated by MSNI scores. Secondary objectives include measuring reductions in chemotherapy dose due to peripheral neuropathy for each subject in both arms, administering a 10 question survey regarding patient acceptability and burden at treatment's end, and using ultrasound imaging to calculate peak systolic velocity on popliteal and posterior tibial arteries pre-and post-intervention."

Answered by AI

Is enrollment for this experiment currently open?

"Affirmative. Clinicaltrials.gov data shows that this trial, which first appeared on 28 September 2017, is recruiting participants. Around 40 candidates are necessary to be enrolled from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Loma Linda Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Gayathri Nagaraj 2017. "Chemotherapy Induced Peripheral Neuropathy (CIPN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03272919.
~6 spots leftby Apr 2025
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