RECRUITING

Daily Hand-Held Vibration Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.

Official Title

Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study

Quick Facts

Study Start:2021-12-06
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04207437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years or older at enrollment
  2. 2. Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  3. 3. Have completed chemotherapy ≥ 60 days prior to enrollment
  4. 4. Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m)
  5. 5. Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy
  6. 6. If solid tumor cancer, must have non-metastatic cancer
  7. 7. Agree to return to clinic for required study related measurements at specified intervals
  1. 1. Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
  2. 2. Known diagnosis of diabetes mellitus.
  3. 3. Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
  4. 4. Will be receiving concurrent radiation of the upper-extremity

Contacts and Locations

Study Contact

Nada Kassem
CONTACT
317-278-5238
nakassem@iu.edu
Lacy Slayton
CONTACT
(317) 278-6718
lslayton@iu.edu

Principal Investigator

Erin Newton, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University Health West
Avon, Indiana, 46123
United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
IU Health Joe & Shelly Schwarz Cancer Center
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Erin Newton, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-06
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-12-06
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Neuropathy
  • Vibration

Additional Relevant MeSH Terms

  • Neuropathy
  • Cancer
  • Chemotherapeutic Drug - Induced Nephropathy
  • Chemotherapeutic Toxicity