Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT05751668
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05751668
Study Brief:
Protocol Section:
NCT05751668