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Finding the right dose of GM1 to reduce nerve damage from chemotherapy in breast cancer patients

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

Phase 2 Interventional Alliance for Clinical Trials in Oncology · NCT05751668

This study is testing the right dose of a substance called GM1 to see if it can help reduce nerve damage and improve quality of life for breast cancer patients undergoing chemotherapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment98 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations33 sites (Irvine, California and 32 other locations)
Trial IDNCT05751668 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the safety and efficacy of monosialotetrahexosylganglioside (GM1) in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with metastatic breast cancer receiving paclitaxel. The study aims to determine the optimal dose of GM1 and assess its impact on sensory symptoms associated with CIPN, such as numbness and pain. Participants will be monitored for side effects and quality of life through questionnaires. The trial also seeks to explore the relationship between GM1 and the effectiveness of paclitaxel in treating cancer.

Who should consider this trial

Good fit: Ideal candidates include individuals with a histologic diagnosis of metastatic breast cancer who are scheduled to receive paclitaxel and have minimal pre-existing neuropathy.

Not a fit: Patients with a history of significant neurological disorders or those currently experiencing severe CIPN symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of painful nerve damage in breast cancer patients undergoing chemotherapy.

How similar studies have performed: While similar approaches have been explored, this specific use of GM1 for CIPN in breast cancer patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Irvine, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Anatomic Stage IV Breast Cancer AJCC v8Chemotherapy-Induced Peripheral NeuropathyMetastatic Breast Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.