NCT05751668Active, not recruitingPhase 2
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel
An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 21 Feb 2023
- Start date
- Nov 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05751668
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 7
- From Nov 2023 to the primary completion date, Nov 2026
- 33 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- N/A
Who the study is looking for
- Documentation of disease: Histologic diagnosis of metastatic breast cancer in women or men
- Prior treatment- No previous exposure to GM1
- Planned administration of paclitaxel, either given weekly, or weekly 3 weeks on/1 week off, to patients with metastatic cancer at a dose of 80 mg/m\^2
- No planned treatment with concurrent immunotherapy
- Score of 1 (none) and/or 2 (a little) on the six individual European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)- chemotherapy-induced peripheral neuropathy (CIPN)20 questions that quantify numbness (N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)
- No diagnosis of fibromyalgia
- No history of significant respiratory tract infection and/or infectious diarrhea within 14 days before registration
- No history of stroke or cerebrovascular accident in the past 6 months prior to registration
- No history of diagnosed neurologic or psychiatric disorders, including epilepsy or dementia
- For women of childbearing potential, not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Therefore, for women of childbearing potential, a negative pregnancy test done =\< 7 days prior to registration is required. Of note, a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to complete questionnaires by themselves or with assistance
- In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English and/or Spanish
- Persons with impaired decision making such that they cannot understand the benefits or risks of trial participation, per the judgement of the consenting clinician, will not be eligible
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- Platelet count \>= 100,000/mm\^3
- Creatinine =\< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
- Total bilirubin =\< 1.5 x ULN
- No planned use of duloxetine
- No planned use of cryotherapy, compression therapy, or cryocompression therapy at study entry
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Coordinator of this site? Confirm its status | Ankeny | United States | Unknown status |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Oncology Associates at Mercy Medical Center Coordinator of this site? Confirm its status | Cedar Rapids | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Cedar Rapids | United States | Unknown status |
| Saint Luke's Hospital Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| Morton Plant Hospital Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Southeastern Medical Oncology Center-Clinton Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Coordinator of this site? Confirm its status | Clive | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Southeastern Medical Oncology Center-Goldsboro Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Legacy Mount Hood Medical Center Coordinator of this site? Confirm its status | Gresham | United States | Unknown status |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Southeastern Medical Oncology Center-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Marshfield Medical Center - Minocqua Coordinator of this site? Confirm its status | Minocqua | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Legacy Good Samaritan Hospital and Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Coborn Cancer Center at Saint Cloud Hospital Coordinator of this site? Confirm its status | Saint Cloud | United States | Unknown status |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Unknown status |
| Saint Anthony's Hospital Cancer Care Center Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Toledo Clinic Cancer Centers-Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Legacy Meridian Park Hospital Coordinator of this site? Confirm its status | Tualatin | United States | Unknown status |
| Legacy Cancer Institute Medical Oncology and Day Treatment Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Legacy Salmon Creek Hospital Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.