Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 3NCT06994507
GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
A Phase 3 study testing GM1 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- GM1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily sign the informed consent form;
- Age: 18 to 75 years old;
- Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;
- ECOG: 0-1
- Adequate organ function level
- Glycated hemoglobin (HbA1c) < 7.0%;
- For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.
- Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.
Who cannot join
- Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;
- There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).
- History of another malignant tumors (except breast cancer)
- Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
- Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
- Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;
- Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing
ZeFei Jiang, PHD, 010-66947175, jzf-cscobc@csco.org.cn
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )
This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.
Read the detailed description
This study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. All patients received GM1/ placebo treatment + chemotherapy.
The main purpose of this study is to evaluate the effectiveness of GM1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. The primary endpoint was the end of GM1 treatment in cycle 4 (C4D21), and the proportion of patients whose FACT/GOG-Ntx score changed by more than 12 points from baseline.
- Being tested
- GM1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM1Drug
GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.
PlaceboDrug
Placebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.
| Study group | Role | What they receive |
|---|---|---|
| GM1 400mg | Experimental | Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle Receives: Drug: GM1 |
| Placebo | Placebo comparator | Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment
Measured: At the end of Cycle 4 (21day/Cycle）
Secondary outcomes (4)
The incidence of grade ≥2 (CTCAE) CIPN
The incidence of grade ≥2 (CTCAE) CIPN
Measured: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
Assessment of functional impairment
Vibration sensitivity test and Grooved pegboard test
Measured: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
Assessment of Quality of Life
Assessment of Quality of Life（QLQ C30）
Measured: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the sixth cycle of treatment
Measured: At the end of Cycle 6 (21day/Cycle）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994507
- Sponsor's protocol ID
- QLGM1-CIPN-301
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )
- ClinicalTrials.gov ID
- NCT06994507
- Acronym / sponsor ID
- QLGM1-CIPN-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 May 2025 (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.
This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.
Detailed description
This study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. All patients received GM1/ placebo treatment + chemotherapy.
The main purpose of this study is to evaluate the effectiveness of GM1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. The primary endpoint was the end of GM1 treatment in cycle 4 (C4D21), and the proportion of patients whose FACT/GOG-Ntx score changed by more than 12 points from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GM1 400mg | Experimental | Drug: GM1Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle |
| Placebo | Placebo comparator | Drug: PlaceboAlbumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle |
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)
- Voluntarily sign the informed consent form;
- Age: 18 to 75 years old;
- Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;
- ECOG: 0-1
- Adequate organ function level
Key exclusion criteria (7 listed)
- Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;
- There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).
- History of another malignant tumors (except breast cancer)
- Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
- Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
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 |
|---|---|---|
| GM1GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle. | Drug | GM1 400mg |
| PlaceboPlacebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle. | Drug | Placebo |
Primary outcome
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
Time frame: At the end of Cycle 4 (21day/Cycle）
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment
4 secondary outcomes
The incidence of grade ≥2 (CTCAE) CIPN
Time frame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
Assessment of functional impairment
Time frame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
Assessment of Quality of Life
Time frame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
Time frame: At the end of Cycle 6 (21day/Cycle）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GM1 in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Qilu Pharmaceutical Co., Ltd. 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 7 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZeFei Jiang, Chief Physician (010-66947175, jzf_cscobc@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline (time frame: At the end of Cycle 4 (21day/Cycle）). 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 6 Aug 2025.