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Early Breast CancerPhase 2NCT04222790

A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

A Phase 2 study testing monosialic gangliosides in people with Early Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Taxane-induced peripheral neuropathy (TIPN) caused by 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
159 participants
Where
1 siteChina
Study dates
28 Aug 2020to 21 Apr 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
  • It is expected that the standard chemotherapy regimen containing albumin paclitaxel will be used in the adjuvant / neo-adjuvant chemotherapy regimen. The standard scheme includes: a. Albumin paclitaxel adopts a single-week regimen, 125-150mg / m2 for 12 weeks; b. Albumin paclitaxel Take a 3-week regimen, 260 mg / m2, for a total of 4 cycles. The plan must not contain platinum and other types of purple shirt drugs;
  • 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 109 / L; platelet (PLT) ≥ 90x109 / 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 in the screening period
  • Sign the informed consent.

Who cannot join

  • There are any toxic events of the peripheral nervous system before enrollment, including: FACT-Ntx subscale score <44; ≥ 1 level of peripheral toxicity according to the CTCAE version 4.0 scale; all other pathological symptoms or diseases may affect Assessment of adverse neurotoxic effects;
  • 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.

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Multicenter, Double-blind, Randomized Controlled Phase II Clinical Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

Taxane-induced peripheral neuropathy (TIPN) caused by 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.

Read the detailed description

Taxane induced peripheral neuropathy (TIPN) caused by taxol is a dose limiting toxicity. The discomfort symptoms mainly include numbness, tingling and burning sensation in the glove sock like distribution of the extremities. This symptom can lead to limited activity, damage the self-care ability and social function of patients, and significantly reduce the quality of life of patients, At the same time, it may lead to early termination of chemotherapy and affect tumor treatment. The overall incidence of TIPN is very high. Many studies show that the incidence of TIPN is as high as 80%. CTCAE classifies it into 5 grades, and 25% - 30% of patients can have serious neurotoxicity. However, there are few effective methods for clinical treatment of TIPN, and there is no international consensus on effective treatment. Therefore, it is of great clinical significance and practical value to carry out clinical research on drugs to alleviate TIPN.

Monosialoganglioside (GM1), a member of the ganglioside family, is a kind of glycosylsphingolipid containing sialic acid on the cell membrane of mammalian animals. It is an endogenous substance. Gangliosides are mainly distributed in the outer layer of the cell membrane, especially on nerve endings and dendrites. It is most abundant and mainly expressed in the cell membrane of neurons. It participates in a variety of neurobiological activities, including neuronal differentiation Plasticity and cell survival. There is evidence that the application of GM1 can protect nerve cells, promote the recovery of neural function, and reduce the time of disability. Recent clinical studies on gangliosides have also shown promising results. GM1 effectively alleviates the neurotoxicity caused by docetaxel.

Although there have been previous studies on the effect of gangliosides on relieving the neurotoxicity of docetaxel, studies on the effect of gangliosides on relieving albumin bound paclitaxel have not been seen, and prospective clinical research data of large samples are lacking. In conclusion, the researchers hope to explore effective and reliable drugs to alleviate the peripheral neurotoxicity of albumin bound paclitaxel.

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

    Also called experience group

    The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin paclitaxel (GM1 is a single infusion).

  • PlaceboOther

    Also called control group

    The control group received placebo on days -1, 1, and 2 of albumin paclitaxel (placebo as a single infusion)

Study groups in NCT04222790
Study groupRoleWhat they receive
monosialic gangliosideExperimentalOn the days -1, 1, and 2 of albumin paclitaxel application, 80 mg of monosialic ganglioside were applied (monosialic ganglioside was a single infusion)
Receives: Drug: monosialic gangliosides
PlaceboPlacebo comparatorThe control group received placebo on days -1, 1, and 2 of albumin paclitaxel (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.

  1. Functional Assessment of Cancer Treatment Neurotoxicity Scale （FACT-Ntx）score

    FACT-Ntx scale score 2 weeks after 4 cycles of albumin-bound paclitaxel 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). The scale is graded 0-4. A low score indicates a good effect.

    Measured: 2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

Secondary outcomes (4)

  1. CTCAE Version 4.0 score

    neurotoxicity evaluated by NCI-CTCAE version 4.0 grading scale which classified symptoms as grade 0, 1, 2, 3, or 4. Higher scores indicate more severe neurotoxicity.

    The NCI-CTCAE version 4.0 assessments 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.

    Measured: 1 month Day 1 of Week 1 to 1 year after the last course of chemotherapy

  2. Functional Assessment of Cancer Treatment Neurotoxicity Scale （FACT-Ntx）score

    The scale is graded 0-4. A low score indicates a good effect.

    Measured: 3 months, 6 months, and 12 months after 4 cycles of chemotherapy

  3. functional assesment of cancer therapy-taxane （FACT-Taxane）score

    Compare FACT-Taxane outcome in treatment vs placebo groups at 2 weeks after 4 cycles of chemotherapy. Lower scores indicate worse functional status. Total possible range is 0 to 64.The paclitaxel therapeutic function assessment scale is mainly used to assess baseline peripheral neurotoxicity, and a lower score indicates less neurotoxicity.

    Measured: 2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

  4. Functional Assessment of Cancer Therapy-General （FACT-G）score

    Compare FACT-G outcome in treatment vs placebo groups at 2 weeks after 4 cycles of chemotherapy. Lower scores indicate worse functional status. Total possible range is 0 to 128.The low score of the cancer patients' quality of life scale indicates that the patients' quality of life is better.

    Measured: 2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2020
  2. Study start28 Aug 2020
  3. Primary completion21 Apr 2022
  4. Study completion21 Apr 2022

Resources

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
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04222790
Sponsor's protocol ID
HELEN-004
Status last verified
Nov 2023
First submitted
7 Jan 2020
Last updated
4 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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: finished, as of the sponsor's last update on 4 Dec 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional Assessment of Cancer Treatment Neurotoxicity Scale （FACT-Ntx）score (time frame: 2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04222790.

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 4 Dec 2023.

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