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

Official record

Identifier

NCT05751668

Recruiting locations

country

United States

Interventions studied

PaclitaxelMonosialotetrahexosylgangliosideQuestionnaire AdministrationQuality-of-life assessmentPlacebo Administration

Lead sponsor

Alliance for Clinical Trials in Oncology

Target enrolment

7 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Mar 2, 2023

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Indexed under

Breast Cancer