Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)
Study Information
Alliance Study ID: A222101
NCT Study ID (ClinicalTrials.gov): NCT05751668
Alliance Committee: Cancer Control
Disease or Cancer Type: Breast Cancer
Status: SUSPENDED
Study Description
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.
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Locations (33)
UCI Health – Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Morton Plant Hospital
Clearwater, Florida 33756
United States
Mount Sinai Medical Center
Miami Beach, Florida 33140
United States
Saint Anthony’s Hospital Cancer Care Center
St. Petersburg, Florida 33705
United States
UI Health Care Mission Cancer and Blood – Ankeny Clinic
Ankeny, Iowa 50023
United States
Mercy Hospital
Cedar Rapids, Iowa 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
United States
UI Health Care Mission Cancer and Blood – West Des Moines Clinic
Clive, Iowa 50325
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood – Des Moines Clinic
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood – Laurel Clinic
Des Moines, Iowa 50314
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
United States
Saint Luke’s Hospital
Chesterfield, Missouri 63017
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United States
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
United States
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Marshfield Medical Center – Minocqua
Minocqua, Wisconsin 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Marshfield Medical Center – Weston
Weston, Wisconsin 54476
United States
Data Sources & Contacts
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