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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
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

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Coordinator of this site? Confirm its status
AnkenyUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesUnknown status
Mercy Hospital
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Cedar RapidsUnited StatesUnknown status
Saint Luke's Hospital
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ChesterfieldUnited StatesUnknown status
Morton Plant Hospital
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ClearwaterUnited StatesUnknown status
Southeastern Medical Oncology Center-Clinton
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ClintonUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesUnknown status
Iowa Methodist Medical Center
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Des MoinesUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Southeastern Medical Oncology Center-Goldsboro
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GoldsboroUnited StatesUnknown status
Legacy Mount Hood Medical Center
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GreshamUnited StatesUnknown status
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesUnknown status
Southeastern Medical Oncology Center-Jacksonville
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JacksonvilleUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Mount Sinai Medical Center
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Miami BeachUnited StatesUnknown status
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Legacy Good Samaritan Hospital and Medical Center
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PortlandUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
Coborn Cancer Center at Saint Cloud Hospital
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Saint CloudUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Saint Anthony's Hospital Cancer Care Center
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St. PetersburgUnited StatesUnknown status
Toledo Clinic Cancer Centers-Toledo
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ToledoUnited StatesUnknown status
Legacy Meridian Park Hospital
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TualatinUnited StatesUnknown status
Legacy Cancer Institute Medical Oncology and Day Treatment
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VancouverUnited StatesUnknown status
Legacy Salmon Creek Hospital
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VancouverUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.