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Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT ID: NCT06324344

Last Updated: 2024-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-09-01

Brief Summary

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The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance.

Detailed Description

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Chemotherapy and other cancer treatments can cause damage to the peripheral nerves mainly reflected in severe pain in the upper and/or lower extremities. Additional to pain, cancer treatment may cause loss of balance which affects motor capacity and is a major cause of poor quality of life. There are only minimally effective treatments for CIPN despite over 20 years of research. Few recent studies have suggested that exercise intervention could be effective to restore numbness and motor capacity loss because of CIPN. Unfortunately, conventional rehabilitation programs however suffer from poor adherence and those programs for supervised settings have limitation of access for those who live in the remote areas (e.g., rural area), or could be too frail to travel after chemotherapy. This raised a significant disparity for delivering an effective therapy for those who are living in remote areas or those who are too frail to travel. Therefore, will test Quell® Transcutaneous Electrical Nerve Stimulation device developed by Neurometrix Inc. (Woburn, MA, USA), to mitigate the associated symptoms caused by CIPN. This device utilizes a wireless technology manageable through a smart phone application (Quell App) that also tracks symptom-status.

The investigators institution, Duncan Cancer Center (McNair Campus, Baylor College of Medicine St Luke's, Houston, Texas, USA) supervised by specialists in clinical and surgical oncology, has a high volume of patients that present with CIPN. Therefore, the investigators believe that this institution is a suitable place to perform this sub-study. The premise of this sub-study is that daily basis of TENS therapy could be effective to reduce pain, reduce numbness and improve both motor-capacity and mobility performance leading to improve quality of life in those who suffer from CIPN and have limited access to health care.

Conditions

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Chemotherapy-induced Peripheral Neuropathy Pain Neuropathy

Keywords

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Transcutaneous Electrical Nerve Stimulation Quell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).

Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.

Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Double

Study Groups

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Intervention Group

The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks.

The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

Group Type ACTIVE_COMPARATOR

High-Dose TENS

Intervention Type DEVICE

high-dose TENS device delivers 1 hour of TENS therapy per session.

Placebo Group

The placebo group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks.

The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

Group Type PLACEBO_COMPARATOR

Low-Dose TENS

Intervention Type DEVICE

low-dose TENS device delivers 6 minutes of TENS therapy per session.

Interventions

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High-Dose TENS

high-dose TENS device delivers 1 hour of TENS therapy per session.

Intervention Type DEVICE

Low-Dose TENS

low-dose TENS device delivers 6 minutes of TENS therapy per session.

Intervention Type DEVICE

Other Intervention Names

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High Dose TENS Active Placebo

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 18 years old willing and able to participate in study.
* Able to use an app via smart phone.
* Patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) grades II and III.
* Have undergone chemotherapy with a drug known to cause neurotoxicity.
* Have finished chemotherapy ≥1 month, and still experiences CIPN.

Exclusion Criteria

* Pregnancy or Lactation.
* Nerve Block a week prior to enrollment.
* Peripheral Sensory Neuropathy Grade I and IV.
* Patients applying ointments to the lower extremities.
* Patients with electrical implanted devices such as pacemakers.
* Patients with lower extremity wounds/history of minor/major amputation.
* Planning to undergo any type of chemotherapy in the next 3 months.
* Neuropathy derived from uncontrolled Diabetes Mellitus.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroMetrix, Inc.

INDUSTRY

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bijan Najafi, PhD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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H-50753-B

Identifier Type: -

Identifier Source: org_study_id