Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492070
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-21
Brief Title:
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Prevention of Paclitaxel-Induced Peripheral Neuropathy Randomized Trial of Cryocompression With or Without Cilostazol
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 platinumpaclitaxel 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
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 platinumpaclitaxel 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03905 | REGISTRY | None | None |
| STUDY00007242 | OTHER | None | None |
| Winship6141-24 | OTHER | None | None |
| P30CA138292 | NIH | None | None |