Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04959929

Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:
Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial Summary

This study will perform an early Phase I feasibility study with single-arm, double-baseline repeated measured design. The investigators will test the feasibility of using focal vibration to improve symptoms of persistent CIPN.

Clinical Trial Description

This is an initial Phase I single-site, single-arm, double-baseline repeated measures feasibility study of wearable focal vibration (FV with Myovolt) for persistent chemotherapy-induced peripheral neuropathy. We will enroll up to 15 cancer survivors who are cancer-free and meet all other inclusion/ exclusion criteria, including CIPN symptoms at least 3 months after final chemotherapy infusion. Participants will undergo baseline assessments (V1) of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline (V2). In addition, they complete 7-days of baseline symptom monitoring by diary before starting 6 weeks of daily at-home therapy with a Myovolt wearable FV device. A study coach will check in by phone or video calls during the intervention period. Participants undergo post-testing immediately after the 6-week intervention (V3), and after another 6 weeks without FV (V4). In total, participants attend 3-4 onsite study visits, a 6-week intervention period with weekly remote check-in contact from the study team, and a 6-week intervention-free follow-up period with at least one remote check-in. Participants will keep a provided daily symptom diary during the primary study period (i.e., 6 weeks), and at least weekly in the 6-week follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04959929
Study type Interventional
Source University of Oklahoma
Contact Josiah Rippetoe, BS
Phone 4052711529
Email josiah-rippetoe@ouhsc.edu
Status Recruiting
Phase N/A
Start date February 9, 2023
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05528263 - Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial) N/A
Completed NCT03272919 - Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A
Not yet recruiting NCT06430814 - Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Not yet recruiting NCT05840562 - Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy Phase 3
Completed NCT02553863 - The Effectiveness and Cost-effectiveness of Acupuncture in Managing Chemotherapy-induced Peripheral Neuropathy N/A
Recruiting NCT04786977 - Physiologic Measure of VIPN
Completed NCT03655587 - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy N/A
Completed NCT03687970 - A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) N/A
Terminated NCT04770402 - Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients N/A
Completed NCT03254394 - Lidocaine for Oxaliplatin-induced Neuropathy Phase 1/Phase 2
Completed NCT04367480 - Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy N/A
Recruiting NCT04237194 - A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Completed NCT04843410 - Effect of Exercise in the Management of Peripheral Neuropathy N/A
Terminated NCT03782402 - Cannabinoids for Taxane Induced Peripheral Neuropathy Phase 2
Not yet recruiting NCT06389721 - Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Recruiting NCT05121558 - The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy) Phase 3
Withdrawn NCT04492436 - A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo Phase 2
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT04262778 - Diagnostic of Chemotherapy Induced Neuropathy in Children
Recruiting NCT06324344 - Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A