Clinical trial NCT06324344: Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title: Transcutaneous Electrical Nerve Stimulation for Lower Extremity in Patients With Neurogenic Pain - A Proof Concept Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Pain
Neuropathy
Keywords: Transcutaneous Electrical Nerve Stimulation
Quell
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: NeuroMetrix, Inc.
First posted: 2024-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Level at 8 Weeks From Baseline
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Vibration Perception Threshold at 8 Weeks
timeFrame: week 8
measure: Quality of Life at 8 Weeks
timeFrame: week 8
Other outcomes:
measure: Sural Nerve Conduction Velocity at 8 Weeks
timeFrame: week 8
measure: Stride Time at 8 Weeks
timeFrame: week 8
measure: Cadence at 8 Weeks
timeFrame: week 8
measure: Double-support Phase at 8 Weeks
timeFrame: week 8
measure: Balance at 8 Weeks
timeFrame: week 8
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: