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GM1 for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No planned treatment with concurrent immunotherapy
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years after the end of gm1 treatment
Awards & highlights
Study Summary
This trial is testing a natural nerve protector to see if it can reduce or prevent chemotherapy-induced nerve damage in breast cancer patients.
Who is the study for?
This trial is for adults with metastatic breast cancer who are receiving paclitaxel and have normal liver function, no severe neurological or psychiatric disorders, and can complete questionnaires in English/Spanish. They should not be using certain therapies or drugs like duloxetine, have a recent serious infection, previous GM1 exposure, or plan to use immunotherapy.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of GM1 to see if it reduces or prevents numbness and weakness caused by chemotherapy (CIPN) in patients treated with paclitaxel. It includes quality-of-life assessments compared to a placebo.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, possible nerve damage protection failure leading to CIPN symptoms such as pain, tingling, or numbness despite treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not planning to receive immunotherapy alongside other treatments.
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I am 18 years old or older.
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I have never been treated with GM1.
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I am not planning to use cold treatments or compression therapies as part of my care.
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I have never been diagnosed with a neurological or psychiatric disorder.
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I experience little to no numbness, tingling, or pain in my hands and feet.
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I can take care of myself and am up and about more than half of my waking hours.
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I have not been diagnosed with fibromyalgia.
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I have a confirmed diagnosis of metastatic breast cancer.
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I am not planning to take duloxetine.
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I am scheduled to receive paclitaxel for my metastatic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite response (Phase II)
Maximum Tolerated Dose (Early phase)
Secondary outcome measures
Percentage of patients who received full planned dose of paclitaxel
Rate of grade 3+ Adverse Events
Serially measured patient-reported outcome that best describes the patients' aches/pains at its least in the last 24 hours
+3 moreOther outcome measures
Overall survival (OS)
Patient-reported severity and interference of numbness or tingling in hands or feet
Progression free survival (PFS)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (paclitaxel, GM1)Experimental Treatment4 Interventions
Patients receive GM1 IV 1 hour prior to paclitaxel administration and paclitaxel IV weekly for 12 weeks or 3 weeks on/1 week off for 12 doses.
Group II: Arm II (paclitaxel, placebo)Placebo Group4 Interventions
Patients receive placebo IV 1 hour prior to paclitaxel administration and paclitaxel IV weekly for 12 weeks or 3 weeks on/1 week off for 12 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,343 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,540 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the benefits and risks of participating in this trial.I can speak and/or read English or Spanish.I am not planning to receive immunotherapy alongside other treatments.I am 18 years old or older.I haven't had a serious lung infection or infectious diarrhea in the last 14 days.Your creatinine levels are not higher than 1.5 times the upper limit of normal.I have never been treated with GM1.You have enough infection-fighting white blood cells in your body.I am not pregnant or nursing and have a recent negative pregnancy test.Your AST or ALT levels are not more than 2.5 times the upper limit of normal.I am not planning to use cold treatments or compression therapies as part of my care.I have never been diagnosed with a neurological or psychiatric disorder.I experience little to no numbness, tingling, or pain in my hands and feet.I haven't had a stroke in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.I have not been diagnosed with fibromyalgia.I have a confirmed diagnosis of metastatic breast cancer.N/AI am not planning to take duloxetine.You have enough platelets in your blood (at least 100,000 per cubic millimeter).I am scheduled to receive paclitaxel for my metastatic cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, GM1)
- Group 2: Arm II (paclitaxel, placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this trial ongoing?
"This trial is currently enrolling participants, as indicated by the clinicaltrials.gov website. It was initially posted on May 31st of 2023 and recently updated August 2nd of 2023."
Answered by AI
How many participants is this research study accepting?
"Affirmative. Clinicaltrials.gov hosts evidence that this medical investigation is actively seeking participants, with the original posting on May 31st 2023 and last edit taking place August 2nd of the same year. 98 individuals will be admitted at 5 distinct sites for this research endeavour."
Answered by AI
To what degree has Arm I (paclitaxel, GM1) been determined to be safe for individuals?
"Arm I (paclitaxel, GM1) was rated a 2 on our team's safety scale as it is only in Phase 2. While some evidence for safety exists, there is no data yet to verify efficacy."
Answered by AI
What beneficial consequences are expected to result from this clinical trial?
"The primary objective assessed over 12 months is to identify the Maximum Tolerated Dose (Early phase). Secondary endpoints involve longitudinally measured patient-reported outcomes of aches/pains at its least and on average as well as a percentage count of recipients receiving full planned doses of paclitaxel. To analyze this, penalized splines will be applied in non-parametric fashion for time trends while parametric models are used to assess intervention effects on changes in mean response. Generalised estimating equations with empirical variance estimators are also employed when comparing arms."
Answered by AI
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