Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)

Paused · Phase 2 · Has a placebo group

Conditions studied: Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy, Metastatic Breast Carcinoma

In brief

This 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 cancer 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.

Key facts

Study ID: NCT05751668
Run by: Alliance for Clinical Trials in Oncology
People needed: 98
Starts: 2023-11-02
Expected to finish: 2032-03-15
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Where it is running

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
Morton Plant Hospital — Clearwater, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
Saint Anthony's Hospital Cancer Care Center — St. Petersburg, Florida, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
Mercy Hospital — Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
Iowa Methodist Medical Center — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
Saint Luke's Hospital — Chesterfield, Missouri, United States
Southeastern Medical Oncology Center-Clinton — Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro — Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville — Jacksonville, North Carolina, United States
Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Toledo Clinic Cancer Centers-Toledo — Toledo, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center — Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center — Portland, Oregon, United States
Legacy Meridian Park Hospital — Tualatin, Oregon, United States

Full record on ClinicalTrials.gov

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