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

N/AActive Not RecruitingNCT07409987

Cumhuriyet University140 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Interventions

TENSDEVICE

compressionOTHER

compression interventions

TENS+Compression interventionsDEVICE

In 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Being 18 years of age or older, * Having a diagnosis of metastatic gastrointestinal cancer (stomach, pancreas, colon, rectum), * Being scheduled to receive 6 cycles of chemotherapy, * Having received 1 cycle of oxaliplatin-based chemotherapy (FOLFOX and FOLFİRİNOX), * Not having a diagnosed mental disorder, * Not having skin problems in the areas where TENS and compression applications will be performed, * Having verbally and in writing approved the informed consent form after being informed and explained about the study. Exclusion Criteria: * Having previously received oxaliplatin-based treatment (monotherapy or combination), * Having a pacemaker, * Having a history of any skin sensitivity in the hands and feet, * Having received or currently receiving another neurotoxic chemotherapy agent other than oxaliplatin-based treatment, * Having developed peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional deficiencies, infections, or major systemic disease (diabetes mellitus, etc.)\].

Outcomes

Primary Outcomes

EORTC QLQ-C30 Quality of Life Scale

EORTC QLQ-C30 Version 3.0 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0) is a widely used scale for evaluating the quality of life of cancer patients, developed by Aaronson et al. (2017). The Cronbach's alpha coefficient of the scale was determined to be ≥ 0.70. EORTC QLQ-C30 consists of 3 sub-dimensions and a total of 30 questions.

Time frame: 10 weeks

Secondary Outcomes

EORTC QLQ-CIPN20

CIPN20, a patient self-report questionnaire aimed at supplementing the European Organisation for Cancer Research and Treatment (EORTC) quality of life questionnaire for cancer patients, was developed by Postma et al. (Postma et al., 2005). EORTC guidelines and issues related to CIPN were formulated after a literature review. EORTC CIPN20 (Appendix 3) provides information on CIPN-related symptoms and functional status of patients exposed to neurotoxic or neuroprotective agents.