Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers

Launched by EMORY UNIVERSITY · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to help prevent a common side effect of a chemotherapy drug called paclitaxel, which is often used to treat gynecological cancers like ovarian or cervical cancer. The trial is testing whether a combination of cryocompression therapy, which involves using cold and compression on the legs, is effective by itself or if it works better with a medication called cilostazol that improves blood flow. Participants in the trial will be women aged 18 and older who are starting or have recently completed a specific chemotherapy treatment that includes paclitaxel.

To join the trial, potential participants need to meet certain health criteria, such as not having had paclitaxel treatment before and not having serious health issues like uncontrolled diabetes or heart disease. If eligible, participants can expect to receive either cryocompression, cilostazol, or a combination of both during their treatment period. This study aims to find a safe and effective way to help reduce the numbness and pain in the hands and feet that can occur with chemotherapy, ultimately improving the quality of life for patients undergoing cancer treatment.

Gender

FEMALE

Eligibility criteria

• 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