Effect of Transcutaneous Electrical Nerve Stimulation on CIPN Symptoms

Summary

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and debilitating survivorship conditions for patients with cancer, and one of the most common side effects of chemotherapy treatment. Unfortunately, there are no proven ways to prevent or treat CIPN. Transcutaneous electrical nerve stimulation (TENS) is a method that succeeded to treat different types of pain and needs more investigation on its effect on CIPN.

Aim : The aims of this study are to investigate the effect of TENS in reducing CIPN symptoms in patients with cancer and to investigate the relathionship between some of the patients' sociodemographic charestristics/ medical history and the levels of CIPN after treatment with TENS.

Method : A double blind parallel randomized controlled trial (RCT) will be used in this study to assess the effect of TENS on CIPN among patients with cancer treated with chemotherapy. Participants will be recruited from King Hussein Cancer Center (KHCC). 44 patients will be included in the study if they developed CIPN after the first cycle of chemotherapy treatment, were ≥18 years old, and were not previously received any session of TENS device and only on gabapentin drug currently. Patients will be randomly assigned to one of two groups, 22 patient for each group. The intervention group will receive the TENS sessions daily for 10 days and for 30 minutes each session. The control group will stay on gabapentin. CIPN will be assessed using the Arabic Version of the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool. CIPN will be assessed three time during the study: first time will be pre-intervention, second time will be after 5 days of treatment and the third time will be at the end of the sessions.

Implication : The result will lead nursing to achieve optimal nursing care for all patients by controlling the pain level and improve other peripheral neuropathy symptoms .

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

Transcutaneous electrical nerve stimulation

The stimulation (TENS) will be performed by a physiotherapist using adhesive electrodes with an area of 5 cm2 in the region where the patient has the symptoms of neuropathy. Further, it will be will be on 10 days consequently, with the same physiotherapist for whole sessions. He will apply electrodes over the affected area, then he will increase the stimulation intensity gradually during the first session when he adjusts the settings till patient reach the maximum voltage that he/she will tolerate it. The evaluations for CIPN patients will be performed by a blinded evaluatorthe PI on the experimental groups at 3 time points; before the begging of the intervention, after 5 days, and after the last session. The intervention group will undergo TENS sessions daily for 10 days for 30 minutes each session ( Gibson et al., 2017). After session completed a structured interview will be conducted, by the primary investigator, to assess for CIPN using the CIPNAT.

Sponsors & Collaborators

• King hussein cancer foundation and center

  collaborator UNKNOWN

• Jordan University of Science and Technology

  lead OTHER

Principal Investigators

• Nour Al-azzam · Jordan University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2024-01-01

Completion

2024-06-29

Countries

• Jordan

Study Locations