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Clinical Trials/NCT06499103
NCT06499103CompletedNot Applicable

Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-induced Peripheral Neuropathy Symptoms

Jordan University of Science and Technology2 sites in 1 country44 target enrollmentStarted: August 8, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
2
Primary Endpoint
Effects of transcutaneous electrical nerve stimulation on chemotherapy-induced peripheral neuropathy symptoms: A randomized controlled trial

Study Overview

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 .

Detailed Description

Chemotherapy Induced Peripheral Neuropathy (CIPN) is a common and serious side effect of chemotherapy treatment that causes autonomic neurons, sensory, or motor nerve damage or dysfunction. CIPN develop in some patients gradually over months to years, while in others may develop rapidly and continue to get worse during or immediately after infusion.

It was found that CIPN can also affected by race and gender. African American women exhibited two to three times higher risk for developing CIPN relative to White Women Further, non-Chinese Asians had a higher risk of developing neuropathy than Chinese or Caucasians in One study (n=255) investigated patients receiving platinum- and taxane based chemotherapy for a variety of solid tumors in Hong Kong, Singapore.

Thus, CIPN need to be managed and solved to prevent CIPN before it occurs and to alleviate symptoms after CIPN has developed. In terms of prophylaxis, American Society of Clinical Oncology (ASCO) practice recommendations state that there is no proven way to prevent, mitigate, or manage CIPN occurrence. Despite trials indicating modest effectiveness, many practitioners explore the use of neuropathic pain medications such as gabapentin, pregabalin, tricyclic antidepressants, and others for symptomatic relief. Nevertheless, only venlafaxine and duloxetine have been shown to be effective in alleviation paresthesia. Duloxetine (orally) is currently the only FDA-approved medication for the treatment of established CIPN and is an ASCO recommended therapy for patients.

Alternative and complementary medicine methods to treat CIPN have also been studied. Firstly, acupuncture is one such technique that is becoming more popular as an effective supplement to other treatments for CIPN. Secondly, Neuromodulation involves electrical stimulation of peripheral nerves (e.g., transcutaneous electrical nerve stimulators, Scrambler therapy) or modulation of the central processing of painful afferent impulses via real-time feedback using electroencephalography to "retrain" the brain to perceive neuropathic pain as a nonpainful stimulus (e.g. neurofeedback). Thirdly, scrambler treatment for CIPN has mainly favorable results, although heterogeneity and small sample sizes restrict it. Fourthly, exercise and cannabinoids are two treatments for CIPN that have a growing body of clinical and preclinical data to back them up.

Transcutaneous Electrical Nerve Stimulation (TENS) has considered as an alternative treatment to conventional pharmacotherapy for cancer patients having CIPN. TENS machine is a non-invasive, inexpensive therapy, operated by a battery. It activates peripheral nerves by delivering low-voltage electrical impulses to control any type of pain (localized, acute or chronic) through 2 -4 sticky electrodes connect via wires placed on the surface of skin, which could blocks or changes the perception of pain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nour Alazam

Principal Investigator

Jordan University of Science and Technology

Study Sites (2)

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