Clinical trial · Interventional
TENS, Compression, and Cryotherapy for Paclitaxel-Induced Peripheral Neuropathy in Women With Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-Induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression Therapy | Other | — | UNRESOLVED |
| Cryotherapy | Other | — | UNRESOLVED |
| Transcutaneous Electrical Nerve Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Transcutaneous Electrical Nerve Stimulation (TENS)
- description
- Participants randomized to this arm received transcutaneous electrical nerve stimulation (TENS) once weekly during weekly paclitaxel sessions from week 3 through week 12, 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 (5 × 5 cm or 5 × 9 cm, as appropriate). Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. Conventional high-frequency TENS was administered at 80 Hz with a pulse duration of 200-250 microseconds. Intensity was increased 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 tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion.
- interventionNames
- Device: Transcutaneous Electrical Nerve Stimulation
- type
- EXPERIMENTAL
- label
- Compression Therapy
- description
- Participants randomized to this arm received compression therapy once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to 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; the 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female and 18 years of age or older. * Diagnosed with early-stage or locally advanced breast cancer. * Receiving 12 weeks of weekly paclitaxel as adjuvant treatment. * Clinically confirmed National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Grade 2 peripheral sensory neuropathy during the third week of paclitaxel treatment, before the third weekly infusion and randomization. * Eastern Cooperative Oncology Group performance status of 0-2 and Karnofsky Performance Status greater than 70. * Able to communicate and complete the study procedures. * Provided written informed consent to participate. Exclusion Criteria: * Peripheral neuropathy present before initiation of paclitaxel treatment. * Diabetic neuropathy or another neurological disorder that could affect the assessment of peripheral neuropathy. * Receiving paclitaxel as neoadjuvant, metastatic, or palliative treatment. * Cardiac pacemaker or another implanted electronic device contraindicating transcutaneous electrical nerve stimulation. * Active infection, open wound, serious skin lesion, or clinically significant peripheral circulatory impairment in the upper or lower extremities where the interventions would be applied. * Raynaud phenomenon, cryoglobulinemia, cold urticaria, or another clinical condition contraindicating cryotherapy. * Regularly receiving another physical intervention for chemotherapy-induced peripheral neuropathy outside the study at enrollment or planning to receive such an intervention during the study.
References
Publications (0)
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