Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
SUSPENDED
NCT05751668
PHASE2

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2023-11-02

Completion Date

2032-03-15

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Paclitaxel

Given IV

DRUG

Monosialotetrahexosylganglioside

Given IV

OTHER

Questionnaire Administration

Ancillary Studies

OTHER

Quality-of-life assessment

Ancillary Studies

DRUG

Placebo Administration

Given IV

Locations (33)

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

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, United States

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States