Early Breast CancerPhase 2NCT04538833
GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
A Phase 2 study testing monosialic gangliosides in people with Early Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- monosialic gangliosides
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2020to 22 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Early Breast Cancer
- Being tested
- monosialic gangliosides, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monosialic gangliosidesDrug
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).
PlaceboOther
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)
| Study group | Role | What they receive |
|---|---|---|
| monosialic ganglioside | Experimental | 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) Receives: Drug: monosialic gangliosides |
| Placebo | Placebo comparator | The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel application, (placebo as a single infusion) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-Ntx score
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
Measured: 2 weeks after chemotherapy
Secondary outcomes (4)
CTCAE Version 4.0 score
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
Measured: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-Taxane score
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.
Measured: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-G score
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
Measured: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-Ntx score
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
Measured: 3 months, 6 months, and 12 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start9 Sep 2020
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Why it stopped: In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538833
- Sponsor's protocol ID
- HNCH-BC007
- Status last verified
- Nov 2022
- First submitted
- 30 Aug 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04538833
- Acronym / sponsor ID
- HNCH-BC007
- Conditions
- Early Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monosialic ganglioside | Experimental | Drug: monosialic gangliosidesOn the days -1, 1, and 2 of albumin-bound paclitaxel application, 80 mg of monosialic ganglioside were applied (monosialic ganglioside was a single infusion) |
| Placebo | Placebo comparator | Other: PlaceboThe control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel application, (placebo as a single infusion) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monosialic gangliosidesThe experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin-bound paclitaxel(GM1 is a single infusion). | Drug | monosialic ganglioside |
| PlaceboThe control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion) | Other | Placebo |
Primary outcome
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
4 secondary outcomes
CTCAE Version 4.0 score
Time frame: 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
FACT-G score
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing monosialic gangliosides in people with Early Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-Ntx score (time frame: 2 weeks after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.