Effect of Transcutaneous Electrical Nerve Stimulation on CIPN Symptoms

NCT06499103 | Completed DMC

• 1 other identifier: TENS on CIPN
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer; Chemotherapy; Transcutaneous electrical nerve stimulation; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Effects of transcutaneous electrical nerve stimulation on chemotherapy-induced peripheral neuropathy symptoms: A randomized controlled trial

  Participants scores in CTCAE and visual analog scales that measure the severity of adverse events of treatment and pain score. Retrospectively, showed improvement in both groups. However the interventional group (TENS with gabapentin) showed a higher reduction in total scores of scales compared with control group.

  Baseline

Study Arms (2)

Interventional group

EXPERIMENTAL

The interventional group (n=22) will receive TENS sessions in addition to the prescribes medication (Gabapentinoids). The assessment will be performed at three time points also; before the begging of the intervention, after 5 days, and after the last session.

Device: Transcutaneous electrical nerve stimulation

Control group

NO INTERVENTION

The control group The control group (n=22) will stay on the prescribed oral medication (Gabapentinoids) for at least 4 weeks (Hirayama et al.,2015). The assessment will be performed at three time points by the primary investigator using the Arabic version of CIPNAT . The first assessment will take place prior to the start of the trial, after two weeks of taking the medication, and the final assessment will be done after 4 weeks of receiving oral agents.

Interventions

Transcutaneous electrical nerve stimulation DEVICE

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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients will be invited if they ≥18 years
• were not previously received any session of TENS device
• on gabapentin drug currently

You may not qualify if:

• skin conditions (lesions or open sores)
• cognitive difficulties or trouble understanding
• history of peripheral neuropathy due to receiving neurotoxic chemotherapy
• cardiac pacemakers
• have ever used TENS device treatment
• chronic conditions (diabetes mellitus, brain damage, history of epilepsy, or taking anticonvulsants drugs)
• pregnant women

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• King hussein cancer foundation and center: collaborator

Study Sites (1)

Jordan university of science and technology

Irbid, 21540, Jordan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Nour Al-azzam

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: July 12, 2024
• Study Start: August 8, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 29, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

JO (1)