Clinical trial · Interventional
Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy
CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
- 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)
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Patients who are not eligible for either cryocompression or cryotherapy are included in a control group. The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hilotherm Chemo Care | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cryocompression
- description
- Patients in this group receive cryocompression for the hands.
- interventionNames
- Device: Hilotherm Chemo Care
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy
- description
- Patients in this group receive cryotherapy for the hands.
- interventionNames
- Device: Hilotherm Chemo Care
Primary outcomes (6)
- measure
- NCV (nerve conduction velocity)
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with breast cancer or other gynecological tumors * planned neoadjuvant, adjuvant or palliative chemotherapy * \</= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line) * at least three cycles of chemotherapy with taxanes * written consent * 18 years and older Exclusion Criteria: * PNP \>/= 2 * neuralgia * metastases in bones, metastases in soft tissue (located in skin, hands or feet) * Raynaud syndrome * peripheral arterial ischemia * hand-feet syndrome
References
Publications (0)
Data not yet available