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

Cumhuriyet University

Status: Completed

Conditions: Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients; Oxaliplatin; CIPN - Chemotherapy-Induced Peripheral Neuropathy

Treatments: Device: TENS+Compression interventions; Other: compression; Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT07409987

CumhuriyetU-SBE-SÖ-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)].

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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140 participants in 4 patient groups

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

Experimental group

Description:

TENS

Treatment:

Device: TENS

Other: compression

Device: TENS+Compression interventions

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

Experimental group

Description:

Compression

Treatment:

Device: TENS

Other: compression

Device: TENS+Compression interventions

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

Experimental group

Description:

TENS+Compresion

Treatment:

Device: TENS

Other: compression

Device: TENS+Compression interventions

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

Experimental group

Description:

Control group

Treatment:

Device: TENS

Other: compression

Device: TENS+Compression interventions