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

March 18, 2026 updated by: Sevcan Özkan, Cumhuriyet University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: This study is a four-group study. The efficacy and severity of neuropathy will be compared in TENS,
TENS
Device: TENS
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.
Other Names:
  • ELECTROSTİMÜLATİON
Other: compression
compression interventions
Other Names:
  • COMPRESSİON İNTERVENTİONS
Device: TENS+Compression interventions
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.
Experimental: This study is a four-group study. The severity of neuropathy will be compared in Compression
Compression
Device: TENS
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.
Other Names:
  • ELECTROSTİMÜLATİON
Other: compression
compression interventions
Other Names:
  • COMPRESSİON İNTERVENTİONS
Device: TENS+Compression interventions
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.
Experimental: This study is a four-group study. The severity of neuropathy will be compared in TENS+Compression
TENS+Compresion
Device: TENS
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.
Other Names:
  • ELECTROSTİMÜLATİON
Other: compression
compression interventions
Other Names:
  • COMPRESSİON İNTERVENTİONS
Device: TENS+Compression interventions
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.
Experimental: This study is a four-group study. The severity of neuropathy will be compared in Control
Control group
Device: TENS
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.
Other Names:
  • ELECTROSTİMÜLATİON
Other: compression
compression interventions
Other Names:
  • COMPRESSİON İNTERVENTİONS
Device: TENS+Compression interventions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C30 Quality of Life Scale
Time Frame: 10 weeks
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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-CIPN20
Time Frame: 10 weeks
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.
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity Criteria CTCAE 5.0-NCI
Time Frame: 10 weeks
Designed by the American National Cancer Institute (NCI), CTCAE 5.0 is used to identify and grade unwanted side effects in patients due to chemotherapy or other reasons.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Study Director: Şerife KARAGÖZOĞLU, Proff., Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CumhuriyetU-SBE-SÖ-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Personal information will not be shared. However, the study's measurement results will be shared.

IPD Sharing Time Frame

February 2026 - January 2028

IPD Sharing Access Criteria

Study protocol, Clinical study report, Statistical Analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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