- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538833
GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
November 19, 2022 updated by: Zhenzhen Liu, Henan Cancer Hospital
Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
Taxane-induced peripheral neuropathy (TIPN) caused by albumin-bound paclitaxel is a dose-limiting toxicity.
The main symptoms of discomfort are numbness, tingling, and burning sensations in the glove-sock-like distribution of the limbs.
At present, there are few effective methods for clinical treatment of TIPN, and there is no widely agreed consensus on effective treatment in the world.
Therefore, it is of great clinical significance and practical value to carry out clinical research to explore drugs to relieve TIPN.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients diagnosed with early breast cancer by histology;
- Age ≥18 years old and ≤75 years old
- At least 1-2 cycles of standard chemotherapy regimens containing albumin-bound paclitaxel were used in adjuvant / neoadjuvant chemotherapy regimens, The FACT-Ntx score was ≤ 37, and the remaining chemotherapy cycles were at least 2 cycles. the standard regimen included: a, albumin paclitaxel one-week regimen; b, albumin paclitaxel 3-week regimen. Platinum and other types of neurotoxic drugs shall not be included in the regimen.
- ECOG score of the patient is ≤1;
- Expected survival time ≥ 3 months;
- The function level of main organs must meet the following requirements (no blood transfusion and no use of leukocyte or platelet rising drugs within 2 weeks before screening) Blood routine: neutrophil (ANC) ≥ 1.5x 10^9 / L; platelet (PLT) ≥ 90x10^9 / L; hemoglobin (Hb) ≥ 90g / L; Blood biochemical total bilirubin (TBIL) ≤ 1.5xULN; alanine aminotransferase (AST) and aspartate aminotransferase (AST) not exceeding 2×ULN; blood urea nitrogen (BUN) and creatinine (CR) below 1.5 × ULN;
- FACT-Ntx score is 44 points before the adjuvant / neoadjuvant chemotherapy was given;
- Sign the informed consent.
Exclusion Criteria:
- Other pathological symptoms or diseases may affect the assessment of adverse neurotoxicity before enrollment
- Patients receiving other medications may cause similar adverse neurotoxic effects within 4 weeks before treatment with this regimen, or they may also receive neurotoxic medications at the same time. Including paclitaxel or analogues; vinca alkaloids or analogues; platinums or analogues; cytarabine, thalidomide, bortezomib or cabazine; other drugs or treatments may cause peripheral neurotoxicity;
- Patients with poor overall condition and ECOG score> 1;
- pregnant or lactating women;
- Patients who also suffer from other neurological abnormalities cannot accurately record the occurrence and severity of neurotoxicity;
- The patient is known to be allergic to the test drug or excipient ingredients of these products;
- Patients with hereditary abnormalities of glucose and lipid metabolism (gangliopathies, such as idiopathic and retinopathy of triad families);
- Patients not suitable for ganglioside treatment;
- Patients with severe concurrent diseases may endanger safety and interfere with scheduled treatment, or the combination of diseases may affect the completion of the study, depending on the judgment of the investigator.
- Patients with a clear history of neurological or mental disorders, including epilepsy or dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: monosialic ganglioside
On the days -1, 1, and 2 of albumin-bound paclitaxel application, 80 mg of monosialic ganglioside were applied (monosialic ganglioside was a single infusion)
|
The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin-bound paclitaxel(GM1 is a single infusion).
|
PLACEBO_COMPARATOR: Placebo
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel application, (placebo as a single infusion)
|
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FACT-Ntx score
Time Frame: 2 weeks after chemotherapy
|
The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44.
Higher scores indicate lower side effects
|
2 weeks after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CTCAE Version 4.0 score
Time Frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
Peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, myalgia, arthralgia, and neuralgia were evaluated by the CTCAE 4.0 rating scale.
Each item was divided into 5 levels: 1, 2, 3, 4, 5, Higher indicates higher neurotoxicity
|
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
FACT-Taxane score
Time Frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
The FACT-Taxane scale contains 16 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 64.
The higher the score, the lower the side effects.
|
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
FACT-G score
Time Frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
The FACT-G Scale contains 27 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 108
|
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
|
FACT-Ntx score
Time Frame: 3 months, 6 months, and 12 months after chemotherapy
|
The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44.
Higher scores indicate lower side effects
|
3 months, 6 months, and 12 months after chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 9, 2020
Primary Completion (ACTUAL)
August 22, 2022
Study Completion (ACTUAL)
August 22, 2022
Study Registration Dates
First Submitted
August 30, 2020
First Submitted That Met QC Criteria
September 1, 2020
First Posted (ACTUAL)
September 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 19, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNCH-BC007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early Breast Cancer
-
AstraZenecaRecruitingBreast Cancer, Early Breast CancerUnited States, Canada, United Kingdom, China, Argentina, Australia, Hungary, Netherlands, Korea, Republic of, France, Germany, Italy, Belgium, Bulgaria, India, Mexico, Spain, Vietnam, Colombia, Japan, Peru, Brazil, Malaysia, Taiwan, Tha... and more
-
Hoffmann-La RocheCompletedBreast Cancer, Early Breast CancerSerbia
-
University Hospital TuebingenRecruitingAdvanced/Metastatic Breast Cancer | Breast Cancer (Early Breast Cancer)Germany
-
Wake Forest University Health SciencesAtrium Health NavicentActive, not recruitingBreast Cancer Female | Early-stage Breast CancerUnited States
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
Peking Union Medical College HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Hoffmann-La RocheCompletedEarly Breast CancerFrance, Spain, United States, Korea, Republic of, Canada, United Kingdom, Argentina, Belgium, Germany, Italy, Taiwan, Thailand, Japan, Brazil, Mexico, Czechia, Poland, Russian Federation, Ukraine
-
Consorzio OncotechActive, not recruiting
-
Hoffmann-La RocheCompleted
-
Novartis PharmaceuticalsTerminatedEarly Breast CancerSpain, Singapore, United States
Clinical Trials on monosialic gangliosides
-
Henan Cancer HospitalCompletedEarly Breast CancerChina
-
DDC Clinic - Center for Special Needs ChildrenUnknownGM3 Synthase Deficiency
-
Sun Yat-sen UniversityCompleted
-
Sun Yat-sen UniversityRecruitingBreast Cancer | Chemotherapy-Related Cognitive ImpairmentChina