Advanced or Metastatic Breast CancerNCT06934733
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer
A study testing Oral cryotherapy and Routine oral care in people with Advanced or Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Breast Cancer
- What is being tested?
- Oral cryotherapy and Routine oral care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- May 2025to May 2027
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
- Age ≥ 18 years at the time of informed consent signing.
- Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
- ECOG PS: 0-2 points;
- The expected survival time was more than 3 months;
- Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:
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- Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
- Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
- Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
- Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
- Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.
- Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.
Who cannot join
- Prior TROP2-targeted treatment was administered.
- Patients with active oral mucositis or oral ulcers were excluded.
- Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
- Other conditions where the investigator determines the patient is unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer: A Randomized, Controlled, Multicenter Clinical Study
The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer
- Conditions
- Advanced or Metastatic Breast Cancer
- Being tested
- Oral cryotherapy, Routine oral care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral cryotherapyOther
Patients randomly assigned to the experimental group underwent TROP2-ADC treatment. They continuously held ice cubes and ice water from 15 minutes before the infusion, throughout the infusion process, and for 15 minutes after the infusion. Ice cubes were promptly replaced with fresh ones as they melted. Patients were instructed not to consume any food or liquids orally for 1 hour following the completion of the ice therapy.
Routine oral careOther
Patients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care.
| Study group | Role | What they receive |
|---|---|---|
| Oral cryotherapy | Experimental | Not described Receives: Other: Oral cryotherapy |
| Routine oral care | Other | Not described Receives: Other: Routine oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)
The incidence and severity of oral mucositis at week 8
Measured: From the start of TROP2-ADC treatment to the 8th week
Secondary outcomes (3)
The incidence and severity of oral mucositis at week 12 and week 24
The incidence and severity of oral mucositis at week 12and week 24
Measured: From the start of TROP2-ADC treatment to the 12th and 24th week
Progression-free survival(PFS)
The Time from randomization to tumor progression or death due to any cause
Measured: Up to approximately 28 weeks
Treatment interruption rate
Time from the initial administration of TROP2-ADC to treatment interruption
Measured: Up to approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934733
- Sponsor's protocol ID
- HNCH-MBC17
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer: A Randomized, Controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06934733
- Acronym / sponsor ID
- HNCH-MBC17
- Conditions
- Advanced or Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Apr 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.
The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral cryotherapy | Experimental | Other: Oral cryotherapy |
| Routine oral care | Other | Other: Routine oral care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
- Age ≥ 18 years at the time of informed consent signing.
- Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
- ECOG PS: 0-2 points;
- The expected survival time was more than 3 months;
Key exclusion criteria (4 listed)
- Prior TROP2-targeted treatment was administered.
- Patients with active oral mucositis or oral ulcers were excluded.
- Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
- Other conditions where the investigator determines the patient is unsuitable for study participation.
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 |
|---|---|---|
| Oral cryotherapyPatients randomly assigned to the experimental group underwent TROP2-ADC treatment. They continuously held ice cubes and ice water from 15 minutes before the infusion, throughout the infusion process, and for 15 minutes after the infusion. Ice cubes were promptly replaced with fresh ones as they melted. Patients were instructed not to consume any food or liquids orally for 1 hour following the completion of the ice therapy. | Other | Oral cryotherapy |
| Routine oral carePatients in the control group did not receive oral cryotherapy during the TROP2-ADC infusion but only received routine oral care. | Other | Routine oral care |
Primary outcome
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)
Time frame: From the start of TROP2-ADC treatment to the 8th week
The incidence and severity of oral mucositis at week 8
3 secondary outcomes
The incidence and severity of oral mucositis at week 12 and week 24
Time frame: From the start of TROP2-ADC treatment to the 12th and 24th week
Progression-free survival(PFS)
Time frame: Up to approximately 28 weeks
Treatment interruption rate
Time frame: Up to approximately 28 weeks
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 18 Apr 2025.
- Individual participant dataSharing planned: No
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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 study testing Oral cryotherapy and Routine oral care in people with Advanced or Metastatic 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 12 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Min Yan (+86 15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard) (time frame: From the start of TROP2-ADC treatment to the 8th week). 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 18 Apr 2025.