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NCT06492070 · ClinicalTrials.gov registry record · Phase 2
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
A Phase 2 study of Malignant Solid Neoplasm and Ovarian Carcinoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 3
- Study locations
NCT06492070: Recruiting Phase 2 study of Malignant Solid Neoplasm and Ovarian Carcinoma, sponsored by Emory University.
NCT06492070 is a Phase 2 study of Malignant Solid Neoplasm and Ovarian Carcinoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 70 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06492070, a Phase 2 study of Malignant Solid Neoplasm and Ovarian Carcinoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 3
- Study locations
Study Summary
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 Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Paclitaxel
- OTHER Best Practice
- DRUG Cilostazol
- DEVICE Cryocompression Therapy
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06492070 shows while recruiting
NCT06492070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower).
The record links to 7 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT06492070 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06492070 about?
NCT06492070 is a clinical study titled "Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers". 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 ef...
What is the current status of trial NCT06492070?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-08-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06492070 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Ovarian Carcinoma, Cervical Carcinoma, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma.
What interventions are being tested in trial NCT06492070?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Paclitaxel (DRUG), Best Practice (OTHER), Cilostazol (DRUG), Cryocompression Therapy (DEVICE).
Who is sponsoring clinical trial NCT06492070?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06492070 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06492070's enrollment target sits among peer trials
70 110th of 176 higher than 65 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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