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

PHASE2RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

November 2, 2023

Primary Completion Date

March 15, 2028

Study Completion Date

March 15, 2032

Conditions
Anatomic Stage IV Breast Cancer AJCC v8Chemotherapy-Induced Peripheral NeuropathyMetastatic Breast Carcinoma
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

Trial Locations (33)

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

27534

RECRUITING

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

28328

RECRUITING

Southeastern Medical Oncology Center-Clinton, Clinton

28546

RECRUITING

Southeastern Medical Oncology Center-Jacksonville, Jacksonville

33140

RECRUITING

Mount Sinai Medical Center, Miami Beach

33705

RECRUITING

Saint Anthony's Hospital Cancer Care Center, St. Petersburg

33756

RECRUITING

Morton Plant Hospital, Clearwater

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

43623

SUSPENDED

Toledo Clinic Cancer Centers-Toledo, Toledo

50023

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny

50309

RECRUITING

Iowa Methodist Medical Center, Des Moines

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines

50314

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50325

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

54449

RECRUITING

Marshfield Medical Center-Marshfield, Marshfield

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54482

RECRUITING

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

RECRUITING

Marshfield Medical Center - Minocqua, Minocqua

54701

RECRUITING

Marshfield Medical Center-EC Cancer Center, Eau Claire

54868

RECRUITING

Marshfield Medical Center-Rice Lake, Rice Lake

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

56303

RECRUITING

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

63017

RECRUITING

Saint Luke's Hospital, Chesterfield

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

92612

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine

92868

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

97030

NOT_YET_RECRUITING

Legacy Mount Hood Medical Center, Gresham

97062

NOT_YET_RECRUITING

Legacy Meridian Park Hospital, Tualatin

97210

NOT_YET_RECRUITING

Legacy Good Samaritan Hospital and Medical Center, Portland

98684

NOT_YET_RECRUITING

Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver

98686

NOT_YET_RECRUITING

Legacy Salmon Creek Hospital, Vancouver

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER