NCT06492070RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Emory University
- Diseases
- Cervical cancer, Ovarian cancer
- NCT number
- NCT06492070
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Aug 2024 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with paclitaxel
- Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
- On one or more antiplatelet therapies excluding acetylsalicylic acid
- 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
- Any patient who does not meet criteria to receive chemotherapy
- ARM C: Previous treatment with paclitaxel
- ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment
Other illness
- 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
- High risk uncontrolled arrhythmias
- Ischemic heart disease
- Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol
- Patients unable to consent for themselves, due to cognitive impairment or other reason
- ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason
Lab values
- Diabetes mellitus with hemoglobin A1c \>7.0
- 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
- ARM C: Diabetes mellitus with hemoglobin A1c \>7.0
Other
- EXCLUSION CRITERIA FOR ARMS A and B:
- Any patient unable and/or unwilling to cooperate with all study protocols
- Raynaud's phenomenon
- Active wounds on the hands or feet
- Incarcerated patients
- Patients with contraindications to cilostazol
- ARM C: Any patient unable and/or unwilling to cooperate with all study protocols
- ARM C: Pregnant patients
- ARM C: Incarcerated patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.