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
Emory University
70 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria6
- 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 Criteria28
- 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
Interventions
Undergo standard of care
Given PO
Undergo cryocompression therapy
Given by infusion
Ancillary studies
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06492070