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New hope: natural compound may stop chemo nerve pain

NCT ID NCT05751668

Prevention Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This study tests a natural substance called GM1 to see if it can prevent nerve damage (pain, numbness, tingling) caused by the chemotherapy drug paclitaxel in people with metastatic breast cancer. About 98 participants will receive either GM1 or a placebo alongside their chemo. The goal is to find a safe dose and see if GM1 helps protect nerves without interfering with cancer treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

7 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm chemotherapy-induced neuropathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage IV breast cancer ajcc V8 Chemotherapy-induced peripheral neuropathy Metastatic breast carcinoma

Contacts and locations

Locations

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303, United States

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309, United States

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684, United States

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210, United States

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062, United States

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030, United States

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686, United States

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, 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-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403, United States

  • Saint Anthony's Hospital Cancer Care Center

    St. Petersburg, Florida, 33705, 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

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023, 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

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

    Clive, Iowa, 50325, United States

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.