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NCT05751668RECRUITINGIRB Ready

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

Sponsored by Alliance for Clinical Trials in Oncology

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 98 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel.

Who Can Participate

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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

98 participants

โšง

Gender

ALL

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Sponsor

Alliance for Clinical Trials in Oncology

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

Clearwater

Florida

Location available
View Clearwater location page
RECRUITING

Miami Beach

Florida

Location available
View Miami Beach location page
RECRUITING

St. Petersburg

Florida

Location available
View St. Petersburg location page
RECRUITING

Ankeny

Iowa

Location available
View Ankeny location page
RECRUITING

Cedar Rapids

Iowa

Location available
View Cedar Rapids location page
RECRUITING

Cedar Rapids

Iowa

Location available
View Cedar Rapids location page
RECRUITING

Clive

Iowa

Location available
View Clive location page

๐Ÿ“ And 24 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Neuropathy Treatment in Irvine?

Join others in California exploring innovative treatment options through clinical research

Neuropathy Treatment Options in Irvine, California

If you're searching for Neuropathy treatment in Irvine, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Irvine, Orange, Clearwater and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Neuropathy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 98 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Neuropathy?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Neuropathy

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Neuropathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05751668. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.