NCT07409987

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 31, 2026

Last Update Submit

March 18, 2026

Conditions

CIPN - Chemotherapy-Induced Peripheral NeuropathyOxaliplatinOxaliplatin Induced Peripheral Neuropathy in Cancer Patients

Keywords

Chemotherapy ınduced peripheral neuropathyRandomized studyNursingelectrostimülationcompression

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 weeks

Secondary Outcomes (1)

  • EORTC QLQ-CIPN20

    10 weeks

Other Outcomes (1)

  • Toxicity Criteria CTCAE 5.0-NCI

    10 weeks

Study Arms (4)

This study is a four-group study. The efficacy and severity of neuropathy will be compared in TENS,

EXPERIMENTAL

TENS

Device: TENSOther: compressionDevice: TENS+Compression interventions

This study is a four-group study. The severity of neuropathy will be compared in Compression

EXPERIMENTAL

Compression

Device: TENSOther: compressionDevice: TENS+Compression interventions

This study is a four-group study. The severity of neuropathy will be compared in TENS+Compression

EXPERIMENTAL

TENS+Compresion

Device: TENSOther: compressionDevice: TENS+Compression interventions

This study is a four-group study. The severity of neuropathy will be compared in Control

EXPERIMENTAL

Control group

Device: TENSOther: compressionDevice: TENS+Compression interventions

Interventions

TENSDEVICE

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.

Also known as: ELECTROSTİMÜLATİON
This study is a four-group study. The efficacy and severity of neuropathy will be compared in TENS,This study is a four-group study. The severity of neuropathy will be compared in CompressionThis study is a four-group study. The severity of neuropathy will be compared in ControlThis study is a four-group study. The severity of neuropathy will be compared in TENS+Compression
compressionOTHER

compression interventions

Also known as: COMPRESSİON İNTERVENTİONS
This study is a four-group study. The efficacy and severity of neuropathy will be compared in TENS,This study is a four-group study. The severity of neuropathy will be compared in CompressionThis study is a four-group study. The severity of neuropathy will be compared in ControlThis study is a four-group study. The severity of neuropathy will be compared in TENS+Compression
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.

This study is a four-group study. The efficacy and severity of neuropathy will be compared in TENS,This study is a four-group study. The severity of neuropathy will be compared in CompressionThis study is a four-group study. The severity of neuropathy will be compared in ControlThis study is a four-group study. The severity of neuropathy will be compared in TENS+Compression

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsOver 18 years of age
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 \[tumor compression, nutritional deficiencies, infections, or major systemic disease (diabetes mellitus, etc.)\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CumhuriyetU

Sivas, Turkey (Türkiye)

Location

Related Publications (1)

  • Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7.

    PMID: 38060077RESULT

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Şerife KARAGÖZOĞLU, Proff.

    Cumhuriyet University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 13, 2026

Study Start

January 2, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

March 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
February 2026 - January 2028
Access Criteria
Study protocol, Clinical study report, Statistical Analysis
More information

Locations

TU(1)