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TENS, Compression, and Cryotherapy for Paclitaxel-Induced Peripheral Neuropathy in Women With Breast Cancer
Sponsor: Cumhuriyet University
Summary
This single-center, four-arm, parallel-group randomized controlled trial evaluates transcutaneous electrical nerve stimulation (TENS), compression, and cryotherapy for the management of chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving weekly adjuvant paclitaxel. A total of 140 participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy before the third weekly paclitaxel infusion were randomized in a 1:1:1:1 ratio to TENS, compression, cryotherapy, or routine care. The interventions were administered during weekly paclitaxel sessions from weeks 3 through 12. Outcomes were assessed at baseline before the third weekly infusion and before the sixth, ninth, and twelfth weekly infusions. The primary outcome is the EORTC QLQ-CIPN20 total score during the treatment period.
Official title: Effects of Transcutaneous Electrical Nerve Stimulation, Compression, and Cryotherapy on Chemotherapy-Induced Peripheral Neuropathy and Quality of Life in Women With Breast Cancer Receiving Weekly Adjuvant Paclitaxel: A Four-Arm Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-04-27
Completion Date
2026-08-15
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Transcutaneous Electrical Nerve Stimulation
Conventional high-frequency transcutaneous electrical nerve stimulation (TENS) was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. TENS was delivered using a dual-channel, battery-powered portable digital Bosch TENS device and four self-adhesive hypoallergenic surface electrodes. Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. The device was set to a frequency of 80 Hz and a pulse duration of 200-250 microseconds. Current intensity was increased gradually to produce a strong but comfortable tingling sensation without pain or visible muscle contraction, typically 10-30 mA and up to 60 mA according to participant tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion.
Cryotherapy
Bilateral local cryotherapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. Cryotherapy was applied to both hands and feet using glycerin-containing DETAMED Coolcare Chemotherapy Neuropathy Set cooling gel gloves and socks that completely covered the distal extremities and remained flexible when frozen. The gel gloves and socks were stored for at least 3 hours before each application in a freezer maintained at -20°C to -30°C. Cotton liners were worn under the gloves and socks, and the cooling sets were replaced at standardized intervals. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.
Compression Therapy
Compression therapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to each participant's ankle and calf measurements. The stockings provided 23-32 mmHg pressure at the ankle, with pressure decreasing gradually toward the calf. For the upper extremities, each participant's standard glove size was determined by hand measurement, and two layers of Beybi Gloves surgical gloves one size smaller were applied bilaterally. Hand pressure was not measured directly; application was standardized using the same sizing procedure and double-glove technique. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Fit, skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.
Locations (1)
CumhuriyetU
Merkez, Sivas, Turkey (Türkiye)