Clinical trial · Interventional
Prevention of Paclitaxel Neuropathy With Cryotherapy
NCT02230319CI-TRIAL-00019281unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
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 |
|---|---|---|---|
| Cryotherapy | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
- interventionNames
- Other: Cryotherapy
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
- timeFrame
- From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Secondary outcomes (1)
- measure
- Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Women 18 years of age or older 2. Histologically or cytological proven diagnosis of breast cancer Stage I- III. 3. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting. 4. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 6. Patient signed informed consent. 7. Patient willing and able to comply with scheduled visits and treatment plan. Exclusion Criteria 1. Patient presents with Grade 2 or greater peripheral neuropathy. 2. History of Raynaud's Disease. 3. Patient presents open or poorly-healing wounds on the hands or feet. 4. Patients with cold intolerance. 5. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
References
Publications (0)
Data not yet available
No reference posted for this study.