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Antimicrotubule Agent

Cryocompression + Cilostazol for Gynecological Cancers

Phase 2

Recruiting

Led By Susan C Modesitt

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment

Diabetes mellitus with hemoglobin A1c >7.0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month post chemotherapy completion and at 6 months and 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing if cryocompression therapy, alone or combined with cilostazol, can help prevent nerve damage caused by a common chemotherapy drug, paclitaxel, in patients with

Who is the study for?

This trial is for patients with various gynecological cancers who are undergoing treatment with paclitaxel, a chemotherapy drug. Participants should not have pre-existing conditions that would interfere with the study or pose additional risk.

What is being tested?

The effectiveness of cryocompression therapy alone or combined with cilostazol in preventing numbness, pain, or tingling caused by paclitaxel in patients with gynecologic cancers is being tested.

What are the potential side effects?

Potential side effects may include discomfort from cryocompression therapy and risks associated with cilostazol such as headache, diarrhea, abnormal stools, heart palpitations, and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of cancer and am planning to undergo a specific chemotherapy regimen.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need medication for nerve pain caused by chemotherapy.

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My diabetes is not well-controlled, with an A1c over 7.0.

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I am willing and able to follow all study requirements.

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I have open sores on my hands or feet.

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My liver function is moderately to severely impaired.

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I experience numbness and color changes in my fingers or toes in cold temperatures or stress.

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I have severe, uncontrolled heart rhythm problems.

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My white blood cell count is below 4,000 and my platelet count is under 100,000.

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I cannot take cilostazol due to health reasons.

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I am not eligible for chemotherapy.

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I have been treated with paclitaxel before.

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I am unable to give consent due to cognitive issues.

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My liver isn't working well, with high bilirubin levels.

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My kidney function is poor, with high creatinine levels.

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I am taking medication to prevent blood clots, not including aspirin.

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I have been diagnosed with ischemic heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month post chemotherapy completion and at 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month post chemotherapy completion and at 6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month post chemotherapy completion and at 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in sensation and vibration objective neuropathy scores (Arms A and B)

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)

Secondary study objectives

Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores

Difference in >= grade 2 neuropathy between the two study arms

Difference in sensation and vibration objective neuropathy scores

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (cryocompression and cilostazol)Experimental Treatment4 Interventions

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.

Group II: Arm 2 (cryocompression)Experimental Treatment3 Interventions

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.

Group III: Arm C (standard of care)Active Control2 Interventions

Patients undergo standard of care throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Cilostazol

2012