Cervical Carcinoma, Fallopian Tube Carcinoma, Malignant Solid Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Vulvar Carcinoma
Conditions
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 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.
Interventions
OTHERBest Practice
Undergo standard of care
DRUGCilostazol
Given PO
DEVICECryocompression Therapy
Undergo cryocompression therapy
DRUGPaclitaxel
Given by infusion
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in sensation and vibration objective neuropathy scores (Arms A and B) | At 1 month post chemotherapy completion and at 6 months and 12 months | 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. |
| 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) | At 1 month post chemotherapy completion and at 6 months and 12 months | The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in >= grade 2 neuropathy between the two study arms | At 1 month post chemotherapy completion and at 6 months and 12 months | Will be compared between treatment groups using a chi-square test of independence. |
| Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores | At 1 month post chemotherapy completion and at 6 months and 12 months | 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. |
| Rate of grade 3 adverse events | At 1 month post chemotherapy completion and at 6 months and 12 months | Will be tabulated by group according to Common Terminology Criteria for Adverse Events Grade, System Organ Class and relation to study treatment. |
| Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy | 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 | At 1 month post chemotherapy completion and at 6 months and 12 months | — |
| Difference in sensation and vibration objective neuropathy scores | At 1 month post chemotherapy completion and at 6 months and 12 months | 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. |
Countries
United States
Contacts
Primary ContactSusan Modesitt, MD
Backup ContactSharese Windley
Outcome results
None listed