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Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT03272919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-05-10

No results posted yet for this study

Summary

Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of chemotherapy having a negative impact on the quality of life for cancer survivors due to numbness, decreased sensation, pain (of various intensities in the extremities), gait/balance problems, and difficulty with fine motor skills of the hands and fingers.To date, there are no preventive modalities to mitigate CIPN development.When CIPN becomes intolerable, optimal doses of chemotherapy have to be reduced or discontinued, which may affect a patient's overall survival. Intraneural facilitation (INF) is a technique developed by physical therapists at Loma Linda University after careful study of the structure, pathophysiology and biomechanics of peripheral nerves. The focus of INF is restoration of circulation to an ischemic nerve. INF has been offered to subjects receiving treatment at LLUCC with anecdotal success. The purpose of this study is to evaluate INF as a treatment modality under the rigor of scientific inquiry to determine its effectiveness as a viable treatment option for breast cancer patients with CIPN.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

OTHER

Arm 1: Investigational INF

INF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.

OTHER

Arm 2: standardized muscle stretching and strength

subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Gayathri Nagaraj, MD · Loma Linda University Medical Center

  • Ellen D'Errico, PHD · Loma Linda University School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2022-05-25
Completion
2022-05-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272919 on ClinicalTrials.gov