Trial Title:
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
NCT ID:
NCT06492070
Condition:
Cervical Carcinoma
Fallopian Tube Carcinoma
Malignant Solid Neoplasm
Malignant Uterine Neoplasm
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Vulvar Carcinoma
Conditions: Official terms:
Carcinoma
Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cilostazol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Undergo standard of care
Arm group label:
Arm C (standard of care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Drug
Intervention name:
Cilostazol
Description:
Given PO
Arm group label:
Arm A (cryocompression and cilostazol)
Other name:
Pletal
Intervention type:
Device
Intervention name:
Cryocompression Therapy
Description:
Undergo cryocompression therapy
Arm group label:
Arm 2 (cryocompression)
Arm group label:
Arm A (cryocompression and cilostazol)
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Given by infusion
Arm group label:
Arm 2 (cryocompression)
Arm group label:
Arm A (cryocompression and cilostazol)
Other name:
Anzatax
Other name:
Asotax
Other name:
Bristaxol
Other name:
Praxel
Other name:
Taxol
Other name:
Taxol Konzentrat
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm 2 (cryocompression)
Arm group label:
Arm A (cryocompression and cilostazol)
Arm group label:
Arm C (standard of care)
Other name:
Quality of Life Assessment
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 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan Modesitt, MD
Phone:
404-727-9578
Email:
smodesi@emory.edu
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Susan C. Modesitt
Phone:
404-727-9578
Email:
smodesi@emory.edu
Investigator:
Last name:
Susan C. Modesitt
Email:
Principal Investigator
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Susan Modesitt, MD
Phone:
404-727-9578
Email:
smodesi@emory.edu
Start date:
August 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492070
