Chemotherapy-Related Cognitive ImpairmentPhase 3NCT05239663
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
A Phase 3 study testing Ganglioside-Monosialic Acid and 250ml normal saline (NS) in people with Chemotherapy-Related Cognitive Impairment and Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-Related Cognitive Impairment, Breast Cancer
- What is being tested?
- Ganglioside-Monosialic Acid and 250ml normal saline (NS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2022to 31 Jul 2024
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided written and signed informed consent;
- Histologically confirmed invasive ductal carcinoma;
- Planned to received (neo)/adjuvant chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
- Can cope with HVLT-RDR and ADAS-Cog evaluation;
- No prior therapy could induce neurological damage,within 4 weeks
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- Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
- Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
- Compliance with the study protocol.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
- Hypersensitivity to experiment agents or components;
- Women with pregnancy or breast feeding;
- A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- Abnormal baseline impairment of cognitive impairment;
- Poor compliance, unwillingness or inability to follow protocol to continue the study;
- Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.
Read the detailed description
This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.
- Being tested
- Ganglioside-Monosialic Acid, 250ml normal saline (NS)
- Keywords
- Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglioside-Monosialic AcidDrug
Also called neuroprotective agents
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
250ml normal saline (NS)Drug
Also called placebo
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS) Receives: Drug: Ganglioside-Monosialic Acid |
| Control group | Other | standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS) Receives: Drug: 250ml normal saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HVLT R-DR
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy.
Measured: 4 weeks after the completion of adjuvant chemotherapy
Secondary outcomes (2)
HVLT R-DR
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 12 weeks，24 weeks and 36 weeks after the completion of adjuvant chemotherapy.
Measured: 36 weeks after the completion of adjuvant chemotherapy
ADAS-Cog
The change of score for Alzheimer's Disease Assessment Scale-Cognitive,from baseline to 12 weeks，24 weeks and 36 weeks after the completion of adjuvant chemotherapy.
Measured: 36 weeks after the completion of adjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start8 Feb 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Difficulty accruing subjects the study accrual was closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Related Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239663
- Sponsor's protocol ID
- SYSUCC-016
- Status last verified
- Jul 2024
- First submitted
- 7 Feb 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05239663
- Acronym / sponsor ID
- SYSUCC-016
- Keywords
- Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Feb 2022 (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.
The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.
Detailed description
This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Ganglioside-Monosialic Acidstandard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS) |
| Control group | Other | Drug: 250ml normal saline (NS)standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have provided written and signed informed consent;
- Histologically confirmed invasive ductal carcinoma;
- Planned to received (neo)/adjuvant chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
- Can cope with HVLT-RDR and ADAS-Cog evaluation;
Key exclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
- Hypersensitivity to experiment agents or components;
- Women with pregnancy or breast feeding;
- A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- Abnormal baseline impairment of cognitive impairment;
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 |
|---|---|---|
| Ganglioside-Monosialic AcidAlso: neuroprotective agentsStandard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS) | Drug | experimental group |
| 250ml normal saline (NS)Also: placeboStandard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS) | Drug | Control group |
Primary outcome
HVLT R-DR
Time frame: 4 weeks after the completion of adjuvant chemotherapy
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy.
2 secondary outcomes
HVLT R-DR
Time frame: 36 weeks after the completion of adjuvant chemotherapy
ADAS-Cog
Time frame: 36 weeks after the completion of adjuvant chemotherapy
Results and safety
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ganglioside-Monosialic Acid and 250ml normal saline (NS) in people with Chemotherapy-Related Cognitive Impairment and Breast Cancer, run by Sun Yat-sen University 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 9 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: stopped early, as of the sponsor's last update on 1 Aug 2024. 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 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?
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
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?
HVLT R-DR (time frame: 4 weeks after the completion of adjuvant 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 1 Aug 2024.