Clinical trial · Interventional
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial will be preceded by a pilot phase study in 5 patients. This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment. It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elasto-Gel™ | Device | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel and Elasto-Gel™ Cryotherapy
- description
- Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
- interventionNames
- Device: Elasto-Gel™
- Drug: Paclitaxel
- type
- OTHER
- label
- Paclitaxel alone
- description
- Paclitaxel will be administered without cryotherapy.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of written informed consent prior to any study specific procedures. 2. Age ≥ 21 years old 3. Patients with histologically confirmed early or locally advanced breast cancer 4. Must be receiving 12x weekly sessions of paclitaxel as part of their adjuvant or neo-adjuvant chemotherapy 5. Must have routine chemotherapy lab investigations as per institutional practice 6. Concurrent use of Trastuzumab and/or Pertuzumab for cerbB-2 positive patients as per institutional practice is allowed 7. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. Exclusion Criteria: 1. Patients diagnosed with pre-existing or history of peripheral neuropathy (regardless of cause) 2. Patients with history of Raynaud's disease 3. Prior use of taxane-based chemotherapy 4. Concurrent use of other neuro-toxic chemotherapy with paclitaxel 5. Patients who have had any axillary clearance surgery and without a central venous access device for chemotherapy administration 6. Patients with any severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
References
Publications (1)
- DERIVEDNg DQ, Tan CJ, Soh BC, Tan MML, Loh SY, Tan YE, Ong HH, Teng PPC, Chan JJ, Chay WY, Lee J, Lai G, Beh SY, Tan TJY, Yap YS, Lee GE, Wong M, Dent R, Lo YL, Chan A, Loh KW. Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial. Front Neurol. 2020 Dec 18;11:604688. doi: 10.3389/fneur.2020.604688. eCollection 2020. PMID 33424755