Cervical CarcinomaPhase 2NCT06492070
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
A Phase 2 study testing Best Practice, Cilostazol and Cryocompression Therapy in people with Cervical Carcinoma and Fallopian Tube Carcinoma, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Fallopian Tube Carcinoma, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Cilostazol and Cryocompression Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Susan Modesitt, MD, 404-727-9578, smodesi@emory.edu
- Not yet recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Susan C. Modesitt, 404-727-9578, smodesi@emory.edu
Susan C. Modesitt
- Not yet recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Susan Modesitt, MD, 404-727-9578, smodesi@emory.edu
About this study
Official title: Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cervical Carcinoma, Fallopian Tube Carcinoma, Malignant Solid Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Being tested
- Best Practice, Cilostazol, Cryocompression Therapy, Paclitaxel, Quality-of-Life Assessment
- Medical subject headings
- Uterine Cervical Neoplasms, Fallopian Tube Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care
CilostazolDrug
Also called Pletal
Given PO
Cryocompression TherapyDevice
Undergo cryocompression therapy
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given by infusion
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 (cryocompression) | Experimental | 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. Receives: Device: Cryocompression Therapy; Drug: Paclitaxel; Other: Quality-of-Life Assessment |
| Arm A (cryocompression and cilostazol) | Experimental | 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. Receives: Drug: Cilostazol; Device: Cryocompression Therapy; Drug: Paclitaxel; Other: Quality-of-Life Assessment |
| Arm C (standard of care) | Active comparator | Patients undergo standard of care throughout the study. Receives: Other: Best Practice; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in sensation and vibration objective neuropathy scores (Arms A and B)
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.
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
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)
The proportion of patients in Arm C will be tabulated with associated Clopper-Pearson 95% confidence intervals.
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Secondary outcomes (6)
Difference in sensation and vibration objective neuropathy scores
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.
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in >= grade 2 neuropathy between the two study arms
Will be compared between treatment groups using a chi-square test of independence.
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores
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.
Measured: 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
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Rate of grade 3 adverse events
Will be tabulated by group according to Common Terminology Criteria for Adverse Events Grade, System Organ Class and relation to study treatment.
Measured: At 1 month post chemotherapy completion and at 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan Modesitt, Emory University
- Investigators
- Susan C Modesitt, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492070
- Sponsor's protocol ID
- STUDY00007242
- Other IDs
- NCI-2024-03905, STUDY00007242, Winship6141-24, P30CA138292
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol
- ClinicalTrials.gov ID
- NCT06492070
- Acronym / sponsor ID
- STUDY00007242
- Conditions
- Cervical Carcinoma, Fallopian Tube Carcinoma, Malignant Solid Neoplasm, Malignant Uterine Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 2 (cryocompression) | Experimental | Device: Cryocompression Therapy, Drug: Paclitaxel, Other: Quality-of-Life AssessmentPatients 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. |
| Arm A (cryocompression and cilostazol) | Experimental | Drug: Cilostazol, Device: Cryocompression Therapy, Drug: Paclitaxel, Other: Quality-of-Life AssessmentPatients 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. |
| Arm C (standard of care) | Active comparator | Other: Best Practice, Other: Quality-of-Life AssessmentPatients undergo standard of care throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard of care | Other | Arm C (standard of care) |
| CilostazolAlso: PletalGiven PO | Drug | Arm A (cryocompression and cilostazol) |
| Cryocompression TherapyUndergo cryocompression therapy | Device | Arm 2 (cryocompression), Arm A (cryocompression and cilostazol) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven by infusion | Drug | Arm 2 (cryocompression), Arm A (cryocompression and cilostazol) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm 2 (cryocompression), Arm A (cryocompression and cilostazol), Arm C (standard of care) |
Primary outcome
Difference in sensation and vibration objective neuropathy scores (Arms A and B)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Difference in sensation and vibration objective neuropathy scores
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Difference in >= grade 2 neuropathy between the two study arms
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Changes in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-NTX) scores
Time frame: 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
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Differences in the rate of patients requiring paclitaxel dose reductions or chemotherapy delays due to peripheral neuropathy
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Rate of grade 3 adverse events
Time frame: At 1 month post chemotherapy completion and at 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan C Modesitt principal investigator
Emory University Hospital/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Cilostazol and Cryocompression Therapy in people with Cervical Carcinoma and Fallopian Tube Carcinoma, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Modesitt, MD (404-727-9578, smodesi@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in sensation and vibration objective neuropathy scores (Arms A and B) (time frame: At 1 month post chemotherapy completion and at 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.