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Daily Hand-Held Vibration Therapy

Primary Purpose

Neuropathy, Cancer, Chemotherapeutic Drug - Induced Nephropathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibration therapy

About this trial

This is an interventional supportive care trial for Neuropathy focused on measuring Neuropathy, Vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older at enrollment
Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Have completed chemotherapy ≥ 60 days prior to enrollment
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)
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
If solid tumor cancer, must have non-metastatic cancer
Agree to return to clinic for required study related measurements at specified intervals

Exclusion Criteria:

Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
Known diagnosis of diabetes mellitus.
Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
Will be receiving concurrent radiation of the upper-extremity

Sites / Locations

Indiana University Melvin & Bren Simon Cancer CenterRecruiting
IU Health Joe & Shelly Schwarz Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibration Therapy

Arm Description

Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Outcomes

Primary Outcome Measures

Feasibility of recruitment- percentage of patients who agree to participate in the study after screening

Feasibility of compliance- percentage of vibration therapy sessions completed

Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned.

Acceptability of Intervention- percentage of patients who answer agree on acceptability form

percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores

CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms

Secondary Outcome Measures

Change in CIPN Severity via the CIPN20 questionnaire scores

Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)

Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale

Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life

Full Information

NCT ID

NCT04207437

First Posted

December 11, 2019

Last Updated

July 24, 2023

Sponsor

Indiana University

Collaborators

Indiana Clinical and Translational Sciences Institute

1. Study Identification

Unique Protocol Identification Number

NCT04207437

Brief Title

Daily Hand-Held Vibration Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Indiana Clinical and Translational Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Neuropathy, Vibration

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Subjects will be instructed to perform 3-minutes of vibration therapy per hand each day using a hand held vibration device for 4 weeks. The amount of time that subjects perform vibration therapy will be recorded on their Daily Compliance form and subjects will complete questionnaires daily and weekly.

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vibration Therapy

Arm Type

Experimental

Arm Description

Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Intervention Type

Device

Intervention Name(s)

Vibration therapy

Intervention Description

vibration therapy using hand held vibration device

Primary Outcome Measure Information:

Title

Feasibility of recruitment- percentage of patients who agree to participate in the study after screening

Time Frame

recruitment period (up to 1 year after study starts)

Title

Feasibility of compliance- percentage of vibration therapy sessions completed

Description

Time Frame

4 weeks

Title

Acceptability of Intervention- percentage of patients who answer agree on acceptability form

Description

percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form

Time Frame

4 weeks

Title

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores

Description

Time Frame

baseline, week 1, week 2, week 3, week 4

Secondary Outcome Measure Information:

Title

Change in CIPN Severity via the CIPN20 questionnaire scores

Description

Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)

Time Frame

baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

Title

Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale

Description

Time Frame

baseline, week 4, week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older at enrollment Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Have completed chemotherapy ≥ 60 days prior to enrollment 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) 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 If solid tumor cancer, must have non-metastatic cancer Agree to return to clinic for required study related measurements at specified intervals Exclusion Criteria: Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.) Known diagnosis of diabetes mellitus. Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection. Will be receiving concurrent radiation of the upper-extremity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nada Kassem

Phone

317-278-5238

nakassem@iu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Newton, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Melvin & Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nada Kassem

Phone

317-278-5238

nakassem@iu.edu

Facility Name

IU Health Joe & Shelly Schwarz Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nada Kassem

Phone

317-278-5238

nakassem@iu.edu

12. IPD Sharing Statement

Plan to Share IPD

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Daily Hand-Held Vibration Therapy

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