NeurotoxicityPhase 2NCT02500810
Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
A Phase 2 study testing monosialoganglioside in people with Neurotoxicity, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotoxicity
- What is being tested?
- monosialoganglioside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytological and histological confirmation of unresectable locally advanced or metastatic lung cancer diagnosis
- No peripheral nervous system diseases exists before
- Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity
- Enough organ functions reservation and appropriate performance status for chemotherapy
- Expected survival period is more than 3 months
Who cannot join
- Known or assignment of any of these products to test drugs allergic agent composition
- With peripheral neuropathy by any cause before treatment
- With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity
- Patients with poor general condition to receive chemotherapy
- Genetic glucolipid metabolic abnormalities
- Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception
- Patients cann't avoid neurotrophic drugs
- According to the researcher's judgment, the situations inappropriate for patients with ganglioside medication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xiangjuan Ma, 86-010-88196458, juliamarsh@sina.com
About this study
Official title: A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.
Read the detailed description
Lung cancer patients received a single-agent albumin-bound paclitaxel chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and blank control group based on segmented block randomized method. After enrollment, patients will complete at least chemotherapy and GM1 injection/blank control. During the 3w per cycle chemotherapy, albumin-bound paclitaxel is conducted in D1 and D8, GM1(40mg+250ml N.S) is injected from D1 to D8. Neurotoxicity evaluation and quality of life assessment will be conducted every cycle and 3m/6m after the chemotherapy.
- Conditions
- Neurotoxicity
- Being tested
- monosialoganglioside
- Keywords
- neurotoxicity, chemotherapy, monosialoganglioside, prevention
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monosialogangliosideDrug
Also called GM1, Monosialotetrahexosylganglioside Sodium Injection
40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| monosialoganglioside | Experimental | patients receive monosialoganglioside. Receives: Drug: monosialoganglioside |
| control | No intervention | blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of neurotoxicity
Measured: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
Secondary outcomes (2)
time(days）neurotoxicity arise
Measured: up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
Peripheral nerve conduction velocity
Measured: up to 4 weeks after the 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.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Shijitan Hospital, Capital Medical University, Yantai Yuhuangding Hospital, Weifang People's Hospital
- Responsible party
- Principal investigator, Jian Fang, Peking University Cancer Hospital & Institute
- Investigators
- Jian Fang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500810
- Sponsor's protocol ID
- GW-N-1501
- Status last verified
- Jul 2015
- First submitted
- 11 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02500810
- Acronym / sponsor ID
- GW-N-1501
- Conditions
- Neurotoxicity
- Keywords
- neurotoxicity, chemotherapy, monosialoganglioside, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Shijitan Hospital, Capital Medical University, Yantai Yuhuangding Hospital, Weifang People's Hospital
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- 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.
The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.
Detailed description
Lung cancer patients received a single-agent albumin-bound paclitaxel chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and blank control group based on segmented block randomized method. After enrollment, patients will complete at least chemotherapy and GM1 injection/blank control. During the 3w per cycle chemotherapy, albumin-bound paclitaxel is conducted in D1 and D8, GM1(40mg+250ml N.S) is injected from D1 to D8. Neurotoxicity evaluation and quality of life assessment will be conducted every cycle and 3m/6m after the chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monosialoganglioside | Experimental | Drug: monosialogangliosidepatients receive monosialoganglioside. |
| control | No intervention | –blank control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cytological and histological confirmation of unresectable locally advanced or metastatic lung cancer diagnosis
- No peripheral nervous system diseases exists before
- Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity
- Enough organ functions reservation and appropriate performance status for chemotherapy
- Expected survival period is more than 3 months
Key exclusion criteria (8 listed)
- Known or assignment of any of these products to test drugs allergic agent composition
- With peripheral neuropathy by any cause before treatment
- With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity
- Patients with poor general condition to receive chemotherapy
- Genetic glucolipid metabolic abnormalities
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 |
|---|---|---|
| monosialogangliosideAlso: GM1, Monosialotetrahexosylganglioside Sodium Injection40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles. | Drug | monosialoganglioside |
Primary outcome
incidence of neurotoxicity
Time frame: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
2 secondary outcomes
time(days）neurotoxicity arise
Time frame: up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
Peripheral nerve conduction velocity
Time frame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Jian Fang principal investigator
Peking University Cancer Hospital & Institute
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 monosialoganglioside in people with Neurotoxicity, run by Peking University Cancer Hospital & Institute 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Jul 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Fang, MD (86-010-88196479, bcht2_mj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of neurotoxicity (time frame: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel 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 17 Jul 2015.