A chill pill for Chemo's side effects? cooling therapy and a Blood-Flow drug take on nerve pain
NCT ID NCT06492070
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether cryocompression therapy, alone or combined with the drug cilostazol, can prevent peripheral neuropathy in people receiving paclitaxel for gynecologic cancers. Peripheral neuropathy causes numbness, pain, or tingling in the hands and feet and is a common reason patients must reduce their chemo dose. Researchers will compare neuropathy rates among participants receiving cryocompression with or without cilostazol against those receiving standard care, to see if the combination is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cryocompression therapy (cooling and compression garments) with or without the drug cilostazol, given alongside standard paclitaxel chemotherapy.
- What this could lead to
- If it works, this could offer a way to prevent the painful numbness and tingling that often forces cancer patients to reduce or stop their chemotherapy.
- What could go wrong
- This is an early-phase trial with only 70 participants, so the approach may not prove effective or safe. Adding cilostazol could also bring side effects like bleeding or heart palpitations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Saint Joseph's Hospital
NOT_YET_RECRUITINGAtlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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