Using cryocompression and cilostazol to prevent nerve damage from chemotherapy in women with gynecological cancers
Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol
This study is testing if using cryocompression therapy alone or with a medication called cilostazol can help prevent nerve damage from chemotherapy in women with gynecological cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT06492070 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of cryocompression therapy, both alone and in combination with cilostazol, to prevent peripheral neuropathy caused by paclitaxel in women with gynecological cancers. The study involves three arms: one receiving paclitaxel with cryocompression and cilostazol, another receiving paclitaxel with cryocompression alone, and a third group receiving standard care to assess baseline neuropathy rates. The trial aims to quantify the incidence and severity of neuropathy and evaluate the impact of cilostazol on quality of life and the need for symptom management. Safety assessments will also be conducted regarding the use of cilostazol alongside various chemotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older diagnosed with specific gynecological cancers who are scheduled to receive paclitaxel-based chemotherapy.
Not a fit: Patients who are unable or unwilling to cooperate or those not receiving paclitaxel as part of their chemotherapy regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence and severity of chemotherapy-induced peripheral neuropathy in patients undergoing treatment for gynecological cancers.
How similar studies have performed: While the combination of cryocompression and cilostazol is a novel approach, similar studies have shown promise in managing chemotherapy-induced side effects.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Not_yet_recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Susan C Modesitt — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Susan Modesitt, MD
- Email: smodesi@emory.edu
- Phone: 404-727-9578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.