Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel
Public ClinicalTrials.gov record NCT05751668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This early phase/phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Exposure to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a condition of weakness, numbness, and pain from nerve damage (usually in the hands and feet). GM1 is a part of the body's natural system that insulates nerves and helps to protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer patients receiving treatment with paclitaxel.
Study identification
- NCT ID
- NCT05751668
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Interventions
- Paclitaxel Drug
- Monosialotetrahexosylganglioside Drug
- Questionnaire Administration Other
- Quality-of-life assessment Other
- Placebo Administration Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2, 2023 (Actual)
- Primary completion
- Nov 15, 2026 (Estimated)
- Completion
- Nov 15, 2028 (Estimated)
- Last update posted
- Oct 19, 2026
2023 – 2028
United States locations
- U.S. sites
- 33
- U.S. states
- 12
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Saint Anthony's Hospital Cancer Care Center | St. Petersburg | Florida | 33705 | — |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | — |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | — |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | — |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | — |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | 28328 | — |
| Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | 27534 | — |
| Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | 28546 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | — |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | — |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | — |
| Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | 98684 | — |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Marshfield Medical Center - Minocqua | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05751668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05751668 live on ClinicalTrials.gov.