A Phase 2 interventional study of Best Practice and Cilostazol in Cervical Carcinoma, Fallopian Tube Carcinoma and Malignant Solid Neoplasm, sponsored by Emory University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Emory University · Phase 2, Interventional, and Supportive care
Among 47 studies testing paclitaxel in Uterine Cervical Neoplasms — 12 open to participants now, 13 under way, 8 of them phase 3. Paclitaxel · Uterine Cervical Neoplasms.
Among the 47 studies testing paclitaxel in Uterine Cervical Neoplasms, this one is the 22nd largest by planned enrollment of the 46 interventional ones, is one of 2 that started in 2024, is one of 20 in phase 2, reaches primary completion later than 8 of the 12 other live ones, and was the 44th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →12 of the 47 studies testing paclitaxel in Uterine Cervical Neoplasms are open now, in 5 countries. Each count lists the studies.
Paclitaxel: first FDA approval 1992 (TAXOL), first EMA approval 1999. What it is approved for, and how studies give it, is on its page →
Of the 473 Uterine Cervical Neoplasms studies recruiting now, 242 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 2 started in 2024.
Median enrollment 65 across the 46 interventional studies. Of the 19 that completed or were terminated, 7 (37%) have results posted.
1 of 47 have an industry lead sponsor. The 10 most frequent:
Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Emory University has 3 studies filed under Uterine Cervical Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies testing paclitaxel in Uterine Cervical Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04016389University Health Network, TorontoFIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery | 2026-12 |
| NCT06492070Emory UniversityCryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers | 2026-12-31 |
Among the 47 studies testing paclitaxel in Uterine Cervical Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
PRIMARY OBJECTIVES:
I. To quantify the incidence and severity of peripheral neuropathy in women treated with paclitaxel for gynecologic malignancies in conjunction with cryocompression and to assess the impact of cilostazol on the development of peripheral neuropathy. (ARM A and ARM B) II. To quantify the baseline post-chemotherapy neuropathy rates among patients with gynecologic malignancies following standard clinical care practices according to their treating physician. (ARM C)
SECONDARY OBJECTIVES:
I. To estimate the potential impact of cilostazol on quality of life related to chemotherapy-induced peripheral neuropathy.
II. To estimate the potential impact of cilostazol on the need for pharmacologic symptom management for peripheral neuropathy.
III. To estimate the potential impact of cilostazol on chemotherapy dose reductions and delays due to peripheral neuropathy.
IV. To assess the safety of using cilostazol in conjunction with chemotherapy regimens with platinum/paclitaxel with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy.
OUTLINE: Participants are assigned to 1 of 3 arms.
ARM A: Patients receive paclitaxel infusion once daily (QD) and receive cryocompression therapy with cooling compression wraps three times daily (TID) over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol orally (PO) twice daily (BID) beginning with their first paclitaxel infusion continuing until 2 weeks after the final paclitaxel infusion. Treatment with paclitaxel continues for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive paclitaxel infusions QD and receive cryocompression therapy with cooling compression wraps TID for 15 minutes before, during, and after receiving paclitaxel infusions on day 1 of each cycle. Treatment with paclitaxel continues for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
ARM C: Patients undergo standard of care throughout the study.
After completion of study treatment, patients are followed up at 30 days and then up to 1 year.
Inclusion Criteria:
Exclusion Criteria:
Hepatic impairment, moderate to severe (Class B \& C by score)
Pregnant and nursing patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive paclitaxel infusions QD and receive cryocompression therapy with cooling compression wraps TID for 15 minutes before, during, and after receiving paclitaxel infusions on day 1 of each cycle. Treatment with paclitaxel continues up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
Device: Cryocompression Therapy · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Patients receive paclitaxel infusion QD and receive cryocompression therapy with cooling compression wraps TID over 15 minutes before, during, and after receiving paclitaxel infusion on day 1 of each cycle. Patients also receive cilostazol PO BID beginning with their first paclitaxel infusion continuing until 2 weeks after the final paclitaxel infusion. Treatment with paclitaxel continues for up to 6-9 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Cilostazol · Device: Cryocompression Therapy · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Patients undergo standard of care throughout the study.
Other: Best Practice · Other: Quality-of-Life Assessment
Undergo standard of care
Also known as: standard of care, standard therapy
Given PO
Also known as: Pletal
Undergo cryocompression therapy
Given by infusion
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Ancillary studies
Also known as: Quality of Life Assessment
Difference in sensation and vibration objective neuropathy scores (Arms A and B)
Specifically, the primary outcome will be the proportion of patients with abnormal vibration sensation times on at least one great toe or index finger assessed by a validated Neuropathy Assessment instrument. Will be compared between treatment groups (Arms A and B) using a chi-square test of independence.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Rates of impaired sensation and vibration on objective neuropathy testing and ≥ Grade 2 neuropathy among patients who recently completed paclitaxel treatment with standard of care treatment protocols (Arm C)
The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in sensation and vibration objective neuropathy scores
Specifically, the outcome of interest will be the proportion of patients with abnormal vibration sensation times on at least one great toe or index finger assessed by a validated Neuropathy Assessment instrument. Will be compared between treatment groups using a chi-square test of independence.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in >= grade 2 neuropathy between the two study arms
Will be compared between treatment groups using a chi-square test of independence.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores
Will be compared between treatment groups using a chi-square test of independence, as will the proportion of patients experiencing a clinically significant change in FACT/GOG-O-NTX neuropathy scores. Proportion of patients with a clinically significant change in scores (change of 10% or more from baseline) will also be determined.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients starting new pharmacologic therapy for peripheral neuropathy while receiving paclitaxel chemotherapy
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Rate of grade 3 adverse events
Will be tabulated by group according to Common Terminology Criteria for Adverse Events Grade, System Organ Class and relation to study treatment.
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
Of 154 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 99. This study's planned 28 months is below that.
Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Cilostazol · Paclitaxel