Clinical trial · Interventional
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol
NCT06492070CI-TRIAL-00124134recruitingPhase 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 phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Uterine Neoplasm | Malignant Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Cilostazol | Drug | — | UNRESOLVED |
| Cryocompression Therapy | Device | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 2 (cryocompression)
- description
- Patients receive paclitaxel infusions QD and receive cryocompression therapy with cooling compression wraps TID for 15 minutes before, during, and after receiving paclitaxel infusions on day 1 of each cycle. Treatment with paclitaxel continues up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Device: Cryocompression Therapy
- Drug: Paclitaxel
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm A (cryocompression and cilostazol)
- description
- Patients receive paclitaxel infusion QD and receive cryocompression therapy with cooling compression wraps TID over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol PO BID beginning with their first paclitaxel infusion continuing until 2 weeks after the final paclitaxel infusion. Treatment with paclitaxel continues for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * INCLUSION CRITERIA FOR ARMS A and B: * Age 18 years or older * Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and planned chemotherapy regimen of 6-9 cycles of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy * Eastern Cooperative Oncology Group performance status from 0 to 2 * ARM C: Age 18 years or older * ARM C: Diagnosis of uterine, ovarian/fallopian tube/primary peritoneal, cervical, or vulvar cancer and completion of 6-9 cycles of a chemotherapy regimen consisting of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy within the last 3 months * ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2 Exclusion Criteria: * EXCLUSION CRITERIA FOR ARMS A and B: * Any patient unable and/or unwilling to cooperate with all study protocols * Previous treatment with paclitaxel * Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment * Diabetes mellitus with hemoglobin A1c \>7.0 * Hepatic impairment, moderate to severe (Class B \& C by Child-Pugh score) * Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease * Raynaud's phenomenon * Active wounds on the hands or feet * High risk uncontrolled arrhythmias * Ischemic heart disease * Inadequate bone marrow function with white blood count \< 4,000/mm\^3 and platelet count \< 100,000/mm\^3 * Inadequate liver function with serum total bilirubin \>= 1.5mg/dL * Inadequate renal function with serum creatinine \>= 1.5mg/dL * On one or more antiplatelet therapies excluding acetylsalicylic acid * Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol * Pregnant and nursing patients * Patients enrolled in this study who have the potential to become pregnant (have an intact uterus, ovary(ies), and fallopian tube(s), have not entered menopause, and have regular menses) are required to utilize reliable contraception such as celibacy, hormonal contraception (oral pills, implant, injection, ring or patch), intrauterine device (IUD), condom and/or diaphragm with spermicide * Incarcerated patients * Patients unable to consent for themselves, due to cognitive impairment or other reason * Patients with contraindications to cilostazol * Any patient who does not meet criteria to receive chemotherapy * ARM C: Any patient unable and/or unwilling to cooperate with all study protocols * ARM C: Previous treatment with paclitaxel * ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment * ARM C: Diabetes mellitus with hemoglobin A1c \>7.0 * ARM C: Pregnant patients * ARM C: Incarcerated patients * ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason
References
Publications (0)
Data not yet available
No reference posted for this study.