Study on Finding the Best Dose of GM1 to Reduce or Prevent Numbness or Weakness from Paclitaxel Treatment (Phase II)

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05751668

Provider View

This clinical trial is testing the safety and effectiveness of GM1, a natural substance in the body, to see if it can help reduce or prevent nerve damage caused by the chemotherapy drug paclitaxel in patients with metastatic breast cancer.

Patient Parameters

Program Overview

This study aims to find out if GM1, a natural compound that helps protect nerves, can reduce or prevent nerve damage in patients with metastatic breast cancer who are receiving the chemotherapy drug paclitaxel. Paclitaxel can cause a side effect called chemotherapy-induced peripheral neuropathy (CIPN), which leads to numbness, tingling, and pain, usually in the hands and feet. The trial will test different doses of GM1 to find the safest and most effective dose for preventing these symptoms.

Description

The study is divided into two parts: an early phase to find the best dose of GM1, and a Phase II part to test its effectiveness.

In the early phase, patients will receive GM1 through an IV either once a week or three times a week with a week off, before getting paclitaxel.

In Phase II, patients will be randomly assigned to one of two groups:

  • Group 1: Patients will receive GM1 through an IV one hour before getting paclitaxel, which will be given weekly for 12 weeks or in cycles of three weeks on and one week off.
  • Group 2: Patients will receive a placebo (a substance with no active ingredient) through an IV one hour before getting paclitaxel, following the same schedule as Group 1.

The main goals are to see if GM1 is safe and if it can prevent or reduce the symptoms of nerve damage caused by paclitaxel. The study will also look at how GM1 affects the pain caused by paclitaxel and how it might impact the effectiveness of paclitaxel in treating cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of metastatic breast cancer.
  • No previous treatment with GM1.
  • Scheduled to receive paclitaxel treatment, either weekly or in cycles of three weeks on and one week off.
  • No planned treatment with immunotherapy at the same time.
  • Low scores on a questionnaire about numbness, tingling, and pain in the hands and feet.
  • No diagnosis of fibromyalgia.
  • No recent serious infections or strokes.
  • No history of neurological or psychiatric disorders like epilepsy or dementia.
  • Women of childbearing age must not be pregnant or nursing and must have a negative pregnancy test before joining the study.
  • Must be able to complete questionnaires in English or Spanish.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Must have certain blood counts and organ function levels within normal limits.
  • No planned use of certain medications or therapies that could affect the study results.

Exclusion Criteria

  • N/A

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