Status:
RECRUITING
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Carcinoma
Fallopian Tube Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To quantify the incidence and severity of peripheral neuropathy in women treated with paclitaxel for gynecologic malignancies in conjunction with cryocompression and to assess ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06492070
Start Date
August 1 2024
End Date
December 31 2027
Last Update
August 27 2025
Active Locations (3)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342