Clinical Trials Directory

Trials / Completed

CompletedNCT07409987

The Effect of Electrostimulation and Compression Applications on Neuropathy Symptoms and Quality of Life in the Management of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal System Cancer Patients Receiving Oxaliplatin-Based Treatment

The Effect of Electrostimulation and Compression Applications on Neuropathy Symptoms and Quality of Life in Chemotherapy-Induced Peripheral Neuropathy Management in Gastrointestinal Cancer Patients Receiving Oxaliplatin-Based Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Cumhuriyet University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This research was conducted to evaluate the effect of electrostimulation and compression applications on the severity, number, and pain levels of neuropathy symptoms and the quality of life of patients with metastatic gastrointestinal cancer receiving oxaliplatin-based treatment in the management of chemotherapy-induced peripheral neuropathy. The study population consisted of patients with gastrointestinal cancer between 2025-2026 . Data collection tools were administered to patients who met the inclusion criteria and developed chemotherapy-induced peripheral neuropathy. Patients were then stratified by age and gender and assigned to "control group, electrostimulation group, compression group, and electrostimulation+compression group" using block randomization. Statistical power analysis determined the total number of participants in the study as 140 patients, with 35 patients in each group. Patients in the control group benefited from the clinic's standard procedures and received no intervention

Detailed description

Data collection was carried out using the "Patient Demographic Form," the National Cancer Institute CTCAE v5.0 toxicity criteria, the EORTC QLQ-C30 General Quality of Life Scale, the EORTC QLQ-CIPN20 Chemotherapy-Induced Neuropathy Scale, and the Neuropathic Pain Assessment Scale (DN4). The measurement tools used in the study were administered a total of six times (in each cycle): "initial follow-up (2nd cycle, before intervention), 3rd cycle, 4th cycle, 5th cycle, 6th cycle, and 6th month." As a result of the interventions applied to the patients, statistically significant differences were found between the TENS, TENS+Compression, and Compression intervention groups compared to the Control group in terms of General Quality of Life, severity and number of symptoms due to peripheral neuropathy, and pain level (p\<0.05). In conclusion, it can be said that TENS and Compression applications positively contribute to pain, symptom severity, and symptom number caused by peripheral neuropathy in gastrointestinal cancer patients who developed peripheral neuropathy due to oxaliplatin.

Conditions

Interventions

TypeNameDescription
DEVICETENSThis research was conducted to evaluate the effect of electrostimulation and compression applications on the severity, number, and pain levels of neuropathy symptoms and the quality of life of patients with metastatic gastrointestinal cancer receiving oxaliplatin-based treatment in the management of chemotherapy-induced peripheral neuropathy.
OTHERcompressioncompression interventions
DEVICETENS+Compression interventionsIn accordance with the glove size determination procedure and the TENS application procedure, TENS and compression applications were performed sequentially on both hands and both feet. Oxaliplatin treatment lasts a total of 120 minutes (2 hours). Accordingly, the study began with 60 minutes of TENS application, followed by 60 minutes of compression application. Applications continued from 30 minutes before the start of oxaliplatin treatment until 30 minutes after the end of treatment. This procedure was applied to participants with neuropathy grade \>2 who were scheduled to receive a total of 6 chemotherapy cycles, repeated every 14 days, for each course of oxaliplatin treatment.

Timeline

Start date
2025-01-02
Primary completion
2026-02-28
Completion
2026-02-28
First posted
2026-02-13
Last updated
2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07409987. Inclusion in this directory is not an endorsement.