Clinical Trials Logo

Clinical Trial Summary

Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge.

Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy.

Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI.

Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03909464
Study type Observational
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact Annelise Iversen, MSPH
Phone 410-955-7566
Email aiverse1@jhu.edu
Status Recruiting
Phase
Start date November 29, 2017
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Active, not recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Recruiting NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Not yet recruiting NCT03662061 - Assessment of a Multidisciplinary Team Meeting (RCP) in Geriatric Oncology
Completed NCT03272880 - Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers N/A
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Recruiting NCT03548077 - POWERPLAY: Promoting Men's Health at Work N/A
Completed NCT03503838 - A Pilot Study of Online Yoga for MPN Patients N/A
Completed NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity
Completed NCT01447186 - Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men N/A
Not yet recruiting NCT03257969 - Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors N/A
Recruiting NCT02883699 - Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study N/A