Chemotherapy Induced Nausea and VomitingNCT06756022
Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
An observational study of Chemotherapy Induced Nausea and Vomiting, run by Anhui Provincial Children's Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, real-world study of 500 participants with childhood acute lymphoblastic leukemia who are scheduled to receive dolasetron mesylate injection for prophylaxis against chemotherapy-induced nausea and vomiting. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- Dolasetron mesylate injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2024to 31 Dec 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Nausea and vomiting induced by induction chemotherapy in children with acute lymphoblastic leukemia
Who may be able to join
- Age 2~17 years old
- The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensive examination of bone marrow cell morphology, immune typing, cytogenetics and molecular biology.
- The subjects plan to receive induced remission therapy such as VDLP/VDLD+CAM, multicenter CCCG ALL 2015 protocol, SCCCG-ALL-2023 protocol, etc. according to Guidelines for Diagnosis and Treatment of Childhood acute lymphoblastic Leukemia (2018 Edition) for the first time
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
- Expected to survive for more than 3 months
- Subject or guardian can read, understand and complete subject diary.
Who cannot join
- Allergic to Dolasetron mesylate injection and its excipients
- Patients with prolonged QTc interval (QT interval ≥460 ms)
- Other conditions considered by the researchers not to be included in the group.
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
Anhui Children's Hospital
Hefei, Anhui
Tianping Chen, （+86）13855189560, anhuichentp@163.com
About this study
Official title: Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia
This is a prospective, multicenter, real-world study of 500 participants with childhood acute lymphoblastic leukemia who are scheduled to receive dolasetron mesylate injection for prophylaxis against chemotherapy-induced nausea and vomiting.
This study did not make any decision or process intervention for clinical antitumor therapy. The study plans to observe the control of nausea and vomiting within 120 h (D1-D5) after receiving induction chemotherapy and the safety within 7 days (or until this discharge, whichever occurs first).
During the whole study, demographic data, history of motion sickness, ECOG score, complications, name and dosage of anti-tumor therapy drugs, this antiemetic regimen, nausea and vomiting, rescue therapy drugs, combined drugs and adverse events were recorded.
Read the detailed description
Screening period: D-14~D0 (D1 recorded on the day of chemotherapy drug infusion)
Subjects who planned to receive induction chemotherapy for the first time signed informed consent for this study, completed screening period examination, checked the inclusion criteria before drug infusion, and successfully screened subjects received CINV（chemotherapy-induced nausea and vomiting） prophylaxis regimen including Dolasetron mesylate injection.
Treatment observation period: D1~D5 (beginning of study drug administration - 120 h after chemotherapy drug infusion)
Subjects who met all inclusion criteria and did not meet any exclusion criteria were required to complete pre-chemotherapy CINV prophylaxis 30±10 min before induction chemotherapy drug infusion, as described in the administration protocol. The time of starting infusion of chemotherapy drugs (referring to other chemotherapy drugs except hormone drugs in the chemotherapy regimen) was recorded as 0 h, and the subsequent days were calculated as 24 hours.
Within 120 h after the start of chemotherapy infusion, if the subject had at least one episode of vomiting, retching, or nausea and complained of antiemetic therapy, the investigator evaluated the subject and gave remedial antiemetic therapy, which was determined by the investigator.
Within 120 h after the infusion of chemotherapy drugs, the subject or guardian will fill in the occurrence of vomiting/retching and nausea daily through the subject's diary. If there were any omissions in the subjects' diaries, the researchers would remind the subjects to fill in the contents through phone calls and wechat.
Follow-up period: D6~D7 (or until this discharge, whichever occurs first)
Adverse events were collected from D6 to D7 after chemotherapy drug infusion began (or until this discharge, whichever occurred first), and the relevant data were recorded in the study medical records and EDC（Electronic Data Capture） system.
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- Dolasetron mesylate injection
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolasetron mesylate injectionDrug
1.8 mg/kg Dolasetron mesylate injection should be injected intravenously 30±10 min before chemotherapy infusion, with the maximum dose not exceeding 100 mg. It can also be mixed with apple juice or apple-grape juice for oral use, the oral dose is 1.8 mg/kg, the maximum amount is not more than 100 mg, taken orally within 1 h before chemotherapy.
Other antiemetic drugs, except dolasetron, are at the discretion of the subject's supervising physician in accordance with clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy | Subjects with childhood acute lymphoblastic leukemia treated with dolasetron mesylate injection for the prevention of nausea and vomiting induced by induction chemotherapy Receives: Drug: Dolasetron mesylate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (CR) rate during 0-120 hour after chemotherapy (global phase)
CR defined as no vomiting or retching occurring within 120 hours after chemotherapy and no remedial medication being used
Measured: 0-120 hour after chemotherapy
Secondary outcomes (7)
Response (CR) rate 0-24 hour after chemotherapy (acute phase)
CR defined as no vomiting or retching occurring within 24 hours after chemotherapy and no remedial medication being used
Measured: 0-24 hour after chemotherapy
Response (CR) rate 24-120 hour (delayed period) after chemotherapy
CR defined as no vomiting or retching occurring within 24-120 hours after chemotherapy and no remedial medication being used
Measured: 24-120 hour after chemotherapy
Proportion of subjects who did not vomit at 0-24 hour and 24-120 hour after chemotherapy
Data were derived from subjects' diaries；Vomiting defined as even when very small amounts of stomach contents are expelled or retching （muscle movements in which vomiting occurs but stomach contents are not expelled)
Measured: 0-24 hour and 24-120 hour after chemotherapy
Proportion of subjects who did not use rescue treatment 0-24 hour and 24-120 hour after chemotherapy
Data were derived from subjects' diaries；Rescue treatment includes commonly used antiemetic drugs, decided by the investigator
Measured: 0-24 hour and 24-120 hour after chemotherapy
0-120 h after chemotherapy when vomiting (vomiting or retching) first occurs or rescue treatment is given (whichever occurs first)
Data were derived from subjects' diaries；Vomiting defined as even when very small amounts of stomach contents are expelled or retching （muscle movements in which vomiting occurs but stomach contents are not expelled)；Rescue treatment includes commonly used antiemetic drugs, decided by the investigator
Measured: 0-120 hour after chemotherapy
Proportion of subjects free of nausea 0-24 hour and 24-120 hour after chemotherapy
Data were derived from subjects' diaries
Measured: 0-24 hour and 24-120 hour after chemotherapy
The incidence and severity of adverse events (aes) within 7 days after chemotherapy (or until this discharge, whichever occurs first)
Adverse reactions were judged by the investigator
Measured: 7 days after chemotherapy (or until this discharge, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start21 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianping Chen, Anhui Provincial Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756022
- Sponsor's protocol ID
- EYLL-2024-036
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 1 Jan 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06756022
- Acronym / sponsor ID
- EYLL-2024-036
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Anhui Provincial Children's HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jan 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 is a prospective, multicenter, real-world study of 500 participants with childhood acute lymphoblastic leukemia who are scheduled to receive dolasetron mesylate injection for prophylaxis against chemotherapy-induced nausea and vomiting.
This study did not make any decision or process intervention for clinical antitumor therapy. The study plans to observe the control of nausea and vomiting within 120 h (D1-D5) after receiving induction chemotherapy and the safety within 7 days (or until this discharge, whichever occurs first).
During the whole study, demographic data, history of motion sickness, ECOG score, complications, name and dosage of anti-tumor therapy drugs, this antiemetic regimen, nausea and vomiting, rescue therapy drugs, combined drugs and adverse events were recorded.
Detailed description
Screening period: D-14~D0 (D1 recorded on the day of chemotherapy drug infusion)
Subjects who planned to receive induction chemotherapy for the first time signed informed consent for this study, completed screening period examination, checked the inclusion criteria before drug infusion, and successfully screened subjects received CINV（chemotherapy-induced nausea and vomiting） prophylaxis regimen including Dolasetron mesylate injection.
Treatment observation period: D1~D5 (beginning of study drug administration - 120 h after chemotherapy drug infusion)
Subjects who met all inclusion criteria and did not meet any exclusion criteria were required to complete pre-chemotherapy CINV prophylaxis 30±10 min before induction chemotherapy drug infusion, as described in the administration protocol. The time of starting infusion of chemotherapy drugs (referring to other chemotherapy drugs except hormone drugs in the chemotherapy regimen) was recorded as 0 h, and the subsequent days were calculated as 24 hours.
Within 120 h after the start of chemotherapy infusion, if the subject had at least one episode of vomiting, retching, or nausea and complained of antiemetic therapy, the investigator evaluated the subject and gave remedial antiemetic therapy, which was determined by the investigator.
Within 120 h after the infusion of chemotherapy drugs, the subject or guardian will fill in the occurrence of vomiting/retching and nausea daily through the subject's diary. If there were any omissions in the subjects' diaries, the researchers would remind the subjects to fill in the contents through phone calls and wechat.
Follow-up period: D6~D7 (or until this discharge, whichever occurs first)
Adverse events were collected from D6 to D7 after chemotherapy drug infusion began (or until this discharge, whichever occurred first), and the relevant data were recorded in the study medical records and EDC（Electronic Data Capture） system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy | – | Drug: Dolasetron mesylate injectionSubjects with childhood acute lymphoblastic leukemia treated with dolasetron mesylate injection for the prevention of nausea and vomiting induced by induction chemotherapy |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Nausea and vomiting induced by induction chemotherapy in children with acute lymphoblastic leukemia
Key inclusion criteria (6 listed)
- Age 2~17 years old
- The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensive examination of bone marrow cell morphology, immune typing, cytogenetics and molecular biology.
- The subjects plan to receive induced remission therapy such as VDLP/VDLD+CAM, multicenter CCCG ALL 2015 protocol, SCCCG-ALL-2023 protocol, etc. according to Guidelines for Diagnosis and Treatment of Childhood acute lymphoblastic Leukemia (2018 Edition) for the first time
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
- Expected to survive for more than 3 months
Key exclusion criteria (3 listed)
- Allergic to Dolasetron mesylate injection and its excipients
- Patients with prolonged QTc interval (QT interval ≥460 ms)
- Other conditions considered by the researchers not to be included in the group.
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 |
|---|---|---|
| Dolasetron mesylate injection1.8 mg/kg Dolasetron mesylate injection should be injected intravenously 30±10 min before chemotherapy infusion, with the maximum dose not exceeding 100 mg. It can also be mixed with apple juice or apple-grape juice for oral use, the oral dose is 1.8 mg/kg, the maximum amount is not more than 100 mg, taken orally within 1 h before chemotherapy. Other antiemetic drugs, except dolasetron, are at the discretion of the subject's supervising physician in accordance with clinical practice. | Drug | Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy |
Primary outcome
Response (CR) rate during 0-120 hour after chemotherapy (global phase)
Time frame: 0-120 hour after chemotherapy
CR defined as no vomiting or retching occurring within 120 hours after chemotherapy and no remedial medication being used
7 secondary outcomes
Response (CR) rate 0-24 hour after chemotherapy (acute phase)
Time frame: 0-24 hour after chemotherapy
Response (CR) rate 24-120 hour (delayed period) after chemotherapy
Time frame: 24-120 hour after chemotherapy
Proportion of subjects who did not vomit at 0-24 hour and 24-120 hour after chemotherapy
Time frame: 0-24 hour and 24-120 hour after chemotherapy
Proportion of subjects who did not use rescue treatment 0-24 hour and 24-120 hour after chemotherapy
Time frame: 0-24 hour and 24-120 hour after chemotherapy
0-120 h after chemotherapy when vomiting (vomiting or retching) first occurs or rescue treatment is given (whichever occurs first)
Time frame: 0-120 hour after chemotherapy
Proportion of subjects free of nausea 0-24 hour and 24-120 hour after chemotherapy
Time frame: 0-24 hour and 24-120 hour after chemotherapy
The incidence and severity of adverse events (aes) within 7 days after chemotherapy (or until this discharge, whichever occurs first)
Time frame: 7 days after chemotherapy (or until this discharge, whichever occurs first)
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 1 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy Induced Nausea and Vomiting
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
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?
An observational study of Chemotherapy Induced Nausea and Vomiting, run by Anhui Provincial Children's 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 6 inclusion and 3 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 1 Jan 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 Tianping Chen (（+86）13855189560, anhuichentp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (CR) rate during 0-120 hour after chemotherapy (global phase) (time frame: 0-120 hour after 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 Jan 2025.