Prevention trial for Cervical Carcinoma
Official title Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
ClinicalTrials.gov ID: NCT06492070
What this study is testing
What is Cilostazol?
An investigational oral medication being studied for preventing chemotherapy‑induced peripheral neuropathy in patients with gynecologic cancers. It is designed to improve blood flow by inhibiting platelet aggregation.
Also referred to as Pletal.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether cryocompression alone or with cilostazol can prevent numbness, pain, or tingling caused by paclitaxel. It looks at how safe and tolerable the treatments are.
- Who it's for
- You may be able to join if you have a gynecologic cancer and are receiving paclitaxel chemotherapy.
- What's involved
- You will use a cold compression device on your hands and feet during chemo. If assigned, you will also take cilostazol, a medicine that helps blood flow. You will have regular check‑ins to report any numbness or side effects.
- Time commitment
- The study lasts about the time of your chemo cycles, with visits before and after each treatment to monitor symptoms.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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...
- ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.