TENS and Compression for Established Oxaliplatin-Induced Peripheral Neuropathy

Summary

Chemotherapy-induced peripheral neuropathy is a clinically important adverse effect of oxaliplatin-based chemotherapy that may cause sensory symptoms, neuropathic pain, functional limitations, and reduced quality of life. This randomized, open-label, four-arm parallel-group study evaluated the comparative effects of transcutaneous electrical nerve stimulation (TENS), compression, sequential TENS followed by compression, and usual care in 140 adults with metastatic gastrointestinal cancer who developed Grade 2 or higher chemotherapy-induced peripheral neuropathy after the first cycle of oxaliplatin-based chemotherapy. Participants were allocated in a 1:1:1:1 ratio.

The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments before Cycles 3-6, with the score obtained before Cycle 2 included as the baseline covariate. The overall Group×Time interaction represented the primary treatment effect, and the baseline-adjusted between-group comparison before Cycle 6 represented the primary endpoint comparison.

Secondary outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; DN4 total score and DN4-defined neuropathic pain positivity; and clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade. A separate exploratory follow-up assessment was conducted 6 months after Cycle 6.

Conditions

• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Gastrointestinal Cancers

Interventions

DEVICE

TENS

TENS was delivered using the F. Bosch FB2405 TENS+EMS dual-channel device with four 5 × 5-cm surface electrodes placed bilaterally over PC6 and KI1. Program 4 provided a modulated pulse rate of 2-60 Hz and a pulse width of 156-260 microseconds; the nominal pulse rate was set to 40 Hz. The device output was adjustable from 0-80 mA per channel into a 500-Ω load, but no fixed mA value was used. Intensity was individually titrated to a strong, comfortable, non-painful sensory level without visible muscle contraction. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.

DEVICE

Compression Garments

Bilateral compression of the hands and feet was applied using Beybi Sensitive surgical gloves one size smaller than the participant's measured glove size and knee-high Varimed CCL II graduated compression stockings providing 23-32 mmHg. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions. All applications were individually fitted and directly supervised by the same research nurse.

DEVICE

Sequential TENS Plus Compression

Participants received 90 minutes of TENS followed immediately by 90 minutes of bilateral hand-and-foot compression, using the same devices, parameters, electrode placement, gloves, and stockings as in the monotherapy groups. TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion. After TENS was stopped and the electrodes were removed, compression was applied during the remaining 60 minutes of the infusion and for 30 minutes afterward. The total sequential intervention lasted 180 minutes. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.

Sponsors & Collaborators

• Cumhuriyet University

  lead OTHER

Principal Investigators

• Şerife KARAGÖZOĞLU, Proff. · Cumhuriyet University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-02

Primary Completion

2025-07-28

Completion

2026-01-28

Countries

• Turkey (Türkiye)

Study Locations