Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer
NCT ID: NCT02468739
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2015-05-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVES:
Primary Objective:
To evaluate the efficacy of gangliosides in the prevention of neurotoxicity in breast cancer patients treated with taxane-based chemotherapy. That is, to compare the differences in the scores of Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) between the patients treated by GM1(the treatment group) and the placebo (the control group) at 2 weeks after completion of 4-cycles of taxane-based chemotherapy.
Secondary
* To compare the differences in the scores of Eastern Cooperative Oncology Group neuropathy scale between the patients treated by gangliosides (the experimental group) and the placebo (the control group);
* Tocompare the incidence of neurotoxic adverse events caused by taxane-based chemotherapy. That is, the difference between the patients of chemotherapy treated by gangliosides (the experimental group) and the placebo (the control group) in terms of the incidence of neurotoxicity (graded according to the NCI-CTCAE version 4.0 grading scale);
* Assess the safety and tolerance of the two treatment groups (ganglioside and placebo groups).
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy were randomly assigned to receive GM1 (80 mg, Day -1 to Day 2) or placebo treatment.
Treatment group: Monosialotetrahexosylganglioside sodium is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
Placebo group: Placebo is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
The screening and baseline peripheral neurotoxicity assessment was performed 1 day before the start of the first course of taxane-containing chemotherapy.
The subjects will be treated by the study drugs according to the schedule until the completion of established taxane-based adjuvant chemotherapy, the onset of unacceptable toxicity, or when the patient withdraw from the study voluntarily.
Endpoint assessments including FACT-Ntx subscale, CTCAE version 4.0 grading scale and ENS subscales were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy. The follow-up will be carried out until 2 years after the enrollment time of the last patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ganglioside-monosialic acid arm
Patients will receive treatment of adjuvant chemotherapy. Ganglioside-monosialic acid(GM1, 80mg per day) will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2).
Chemotherapy regimens:
Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 \*4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 \*4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses.
The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians.
Ganglioside-monosialic acid
Ganglioside-monosialic sodium is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). The dosages of GM1 are 80mg per day.
placebo arm
Patients will receive treatment of adjuvant chemotherapy. Placebo will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2).
Chemotherapy regimens:
Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 \*4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 \*4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses.
The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians.
placebo
Placebo is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ganglioside-monosialic acid
Ganglioside-monosialic sodium is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). The dosages of GM1 are 80mg per day.
placebo
Placebo is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* Patients having received other drug treatments might cause similar adverse neurotoxic effects within 4 weeks prior to the treatment of this protocol, or receive concurrent neurotoxic drugs. Including: Taxanes or analogues; Vinca alkaloids or analogues; Platinums or analogues; Cytarabine, thalidomide, bortezomib, or procarbazine; Other drugs or treatments might cause peripheral neurotoxicity
* Patients in poor general conditions, with KPS (Karnofsky performance status) scores \< 80;
* Pregnant or lactating women；
* Patients (female) having the possibility of fertility but unwilling or not taking effective contraceptive measures
* Patients also having other neurological abnormalities who cannot accurately record the occurrence and severity of neurotoxicity;
* Patients known allergy to trial drugs or excipient compositions of these products;
* Patients with inherited glucose and lipid metabolism abnormalities (gangliosidosis such as amaurotic family idiocy and retinopathy);
* Patients not suitable for treatment of ganglioside;
* Active infection (depending on the judgment of investigators);
* Patients with serious concurrent diseases might harmful to safety and interfere the scheduled treatment or concomitant diseases might affect the completion of the study, depending on the judgment of investigators.
* Patients with a history of definite neurological or dysphrenia, including epilepsy or dementia.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhong-yu Yuan
chief physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhong-Yu Yuan, M.D.
Role: STUDY_DIRECTOR
Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYSUCC-013
Identifier Type: -
Identifier Source: org_study_id