Malignant Solid TumorsPhase 3NCT07124195
Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting
A Phase 3 study testing Medroxyprogesterone acetate oral suspension, high antiemetic regimen and moderate antiemetic regimen in people with Malignant Solid Tumors and Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if medroxyprogesterone acetate oral suspension (Meishiya®) works to prevent nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) in the whole-process management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumors, Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs
- What is being tested?
- Medroxyprogesterone acetate oral suspension, high antiemetic regimen and moderate antiemetic regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years, regardless of gender;
- Histologically or cytologically confirmed malignant solid tumor;
- No prior exposure to any chemotherapy drugs (antitumor drugs not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not considered as chemotherapy);
- Initially planned to receive single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs;
- Expected survival period ≥ 6 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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- Good organ function, meeting the following criteria:
- Neutrophil count ≥ 1.5×10⁹/L;
- Hemoglobin ≥ 90 g/L;
- Platelet count ≥ 100×10⁹/L;
- Total bilirubin ≤ 1.5×ULN;
- In patients without known liver metastasis, aspartate aminotransferase ≤ 2.5×ULN and/or alanine aminotransferase ≤ 2.5×ULN (for patients with liver metastasis, it can be relaxed to ≤ 5×ULN);
- Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 ml/min;
- Electrocardiogram: QTc ≤ 450 ms (male), QTc ≤ 470 ms (female);
- Echocardiogram: LVEF (left ventricular ejection fraction) ≥ 50%;
- Female subjects of childbearing potential and male subjects whose partners are female of childbearing potential need to use a highly effective contraceptive method from the time of signing the informed consent form until 6 months after the last dose (see Appendix VII); female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before randomization; and must be non-lactating;
- Clearly understand and voluntarily participate in the study, and sign the informed consent form in person.
Who cannot join
- Having received abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy within 7 days before enrollment, or planning to receive such radiotherapy within days 1 to 8 of treatment;
- Planning to receive other moderate to high emetogenic chemotherapy drugs within days 2 to 8 after the first day of chemotherapy;
- Planning to receive chemotherapy regimens including conventional paclitaxel (using castor oil as solvent);
- Having taken drugs with potential antiemetic effects within 2 days before enrollment: 5-HT3 receptor antagonists (e.g., ondansetron, etc.), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclizine, etc.;
- Having started treatment with benzodiazepines or opioids within 2 days before enrollment (except for triazolam, temazepam or midazolam taken alone daily);
- Subjects who started using morphine within 7 days before enrollment (except those taking a stable dose);
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- Having received systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone or prednisolone) or sedative antihistamines (such as diphenhydramine) within 7 days before enrollment (Note: single use of steroids to prevent contrast agent allergy and local or inhaled administration are allowed);
- Having used palonosetron within 14 days before enrollment;
- Having used NK-1 receptor antagonists within 28 days before enrollment;
- Having used specific CYP3A4 substrates (terfenadine, cisapride, astemizole) or CYP3A4 inhibitors (such as ritonavir, clarithromycin, ketoconazole or itraconazole, diltiazem, etc.) within 7 days before enrollment, and having used strong CYP3A4 inducers (such as phenobarbital, rifampicin, phenytoin and carbamazepine, etc.) or specific CYP2D6 substrates (thioridazine, pimozide) within 28 days before enrollment;
- Having vomiting and/or retching, nausea within 24 hours before enrollment;
- Subjects with symptomatic brain metastasis or any symptoms suggesting brain metastasis or intracranial hypertension;
- Accompanied by poorly controlled serous cavity effusions, including pleural effusion, ascites, pericardial effusion (those controlled after treatment and stable for ≥ 2 weeks can be included);
- Having severe cardiovascular diseases within 3 months before enrollment, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial diseases, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] class II to IV), history of severe cardiac conduction abnormalities (such as torsades de pointes);
- Having poorly controlled hypertension before enrollment (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at two consecutive resting measurements);
- Complicated with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive, and HCV-RNA ≥ upper limit of normal), acquired immunodeficiency syndrome (AIDS) or positive HIV test, positive syphilis test;
- Complicated with concomitant diseases that cannot take dexamethasone, such as active infection (e.g., pneumonia) or any uncontrolled diseases (e.g., diabetic ketoacidosis, gastrointestinal obstruction, etc.);
- Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists or dexamethasone; history of thromboembolic diseases within the past 6 months;
- Having participated in other clinical trials within 30 days before enrollment (based on the use of study drugs);
- Subjects considered by the researcher to be unsuitable for participating in this study due to other conditions.
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
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Yana Zhang, 15093230340, Drzhangyana@hotmail.com
Junlan Guo
About this study
Official title: A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting
The goal of this clinical trial is to learn if medroxyprogesterone acetate oral suspension (Meishiya®) works to prevent nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) in the whole-process management. It will also learn about the safety of medroxyprogesterone acetate oral suspension (Meishiya®). The main questions it aims to answer are:
Does medroxyprogesterone acetate oral suspension (Meishiya®) effectively prevent nausea and vomiting induced by single-day MEC/HEC in the whole-process management? What medical problems do participants have when taking medroxyprogesterone acetate oral suspension (Meishiya®)? Researchers will adopt a multicenter, randomized controlled, open-label trial design and compare the effects of medroxyprogesterone acetate oral suspension (Meishiya®) in preventing chemotherapy-induced nausea and vomiting.
Read more
Participants will be:
Stratified based on chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (<55 years vs ≥55 years) Planned to be 126 subjects who are first-time recipients of single-day MEC/HEC for malignant solid tumors Take medroxyprogesterone acetate oral suspension (Meishiya®) as per the study protocol during the chemotherapy period Visit the research centers at specified intervals for checkups and assessments Record details of nausea, vomiting episodes, and any adverse reactions in a diary
Read the detailed description
A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting This study enrolls subjects with malignant solid tumors who are initially planned to receive moderate to high emetogenic chemotherapy (MEC/HEC) drugs. It aims to explore the efficacy and safety of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs. The study adopts a multicenter, randomized controlled, open-label trial design, with a planned enrollment of 126 subjects. Enrolled subjects will be stratified based on the following factors: chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (<55 years vs ≥55 years).
The main interventions are as follows:
Prevention of CINV induced by HEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily) Control group: Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily)
Prevention of CINV induced by MEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) Control group: Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) The trial consists of a screening period, a treatment period, and a safety follow-up period. Eligible subjects after screening will be randomly assigned to the experimental group or the control group in a 1:1 ratio, receive drug treatment according to the trial protocol, and then complete corresponding follow-ups and examinations in accordance with the trial flow chart. During the study, if the researcher assesses that the subject really needs to use rescue antiemetic drugs, rescue treatment can be carried out according to clinical practice. The specific type, usage, dosage, and frequency of the drugs will be determined by the researcher.
- Being tested
- Medroxyprogesterone acetate oral suspension, high antiemetic regimen, moderate antiemetic regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone acetate oral suspensionDrug
Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily)
high antiemetic regimenCombination product
Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily)
moderate antiemetic regimenCombination product
Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Control-revention of CINV induced by HEC chemotherapy drugs | Other | Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily) Receives: Combination Product: high antiemetic regimen |
| Control-Prevention of CINV induced by MEC chemotherapy drugs | Other | Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) Receives: Combination Product: moderate antiemetic regimen |
| Prevention of CINV induced by HEC chemotherapy drugs | Experimental | Not described Receives: Drug: Medroxyprogesterone acetate oral suspension; Combination Product: high antiemetic regimen |
| Prevention of CINV induced by MEC chemotherapy drugs | Experimental | Not described Receives: Drug: Medroxyprogesterone acetate oral suspension; Combination Product: moderate antiemetic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting induced by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs.
The proportion of patients with no nausea during the entire period (Day 1 to Day 21) after the start of chemotherapy administration in the first chemotherapy cycle.
Measured: 42 days
Secondary outcomes (4)
the safety of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting induced by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs.
The proportion of patients with any kind of adverse effects.
Measured: 42 days
Quality of life score assessed by FLIE scale
Quality of life assessed by Functional Living Index-Emesis (FLIE). The FLIE scale ranges from 0 to 108, with higher scores indicating better quality of life (less impact of emesis on daily functioning)
Measured: 42 days
Quality of life score assessed by EORTC QLQ-C30
Quality of life assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This questionnaire includes functional scales (range: 0-100; higher scores indicate better physical/role/emotional functioning) and symptom scales (range: 0-100; higher scores indicate more severe symptoms such as fatigue or pain).
Measured: 42 days
Quality of life score assessed by EQ-5D scale
Quality of life assessed by EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D index score ranges from -0.594 to 1 (in general population norms), with higher scores indicating better health-related quality of life.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124195
- Sponsor's protocol ID
- CHASE012
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 15 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07124195
- Acronym / sponsor ID
- CHASE012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 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 goal of this clinical trial is to learn if medroxyprogesterone acetate oral suspension (Meishiya®) works to prevent nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) in the whole-process management. It will also learn about the safety of medroxyprogesterone acetate oral suspension (Meishiya®). The main questions it aims to answer are:
Does medroxyprogesterone acetate oral suspension (Meishiya®) effectively prevent nausea and vomiting induced by single-day MEC/HEC in the whole-process management? What medical problems do participants have when taking medroxyprogesterone acetate oral suspension (Meishiya®)? Researchers will adopt a multicenter, randomized controlled, open-label trial design and compare the effects of medroxyprogesterone acetate oral suspension (Meishiya®) in preventing chemotherapy-induced nausea and vomiting.
Participants will be:
Stratified based on chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (<55 years vs ≥55 years) Planned to be 126 subjects who are first-time recipients of single-day MEC/HEC for malignant solid tumors Take medroxyprogesterone acetate oral suspension (Meishiya®) as per the study protocol during the chemotherapy period Visit the research centers at specified intervals for checkups and assessments Record details of nausea, vomiting episodes, and any adverse reactions in a diary
Detailed description
A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting This study enrolls subjects with malignant solid tumors who are initially planned to receive moderate to high emetogenic chemotherapy (MEC/HEC) drugs. It aims to explore the efficacy and safety of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs. The study adopts a multicenter, randomized controlled, open-label trial design, with a planned enrollment of 126 subjects. Enrolled subjects will be stratified based on the following factors: chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (<55 years vs ≥55 years).
The main interventions are as follows:
Prevention of CINV induced by HEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily) Control group: Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily)
Prevention of CINV induced by MEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) Control group: Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) The trial consists of a screening period, a treatment period, and a safety follow-up period. Eligible subjects after screening will be randomly assigned to the experimental group or the control group in a 1:1 ratio, receive drug treatment according to the trial protocol, and then complete corresponding follow-ups and examinations in accordance with the trial flow chart. During the study, if the researcher assesses that the subject really needs to use rescue antiemetic drugs, rescue treatment can be carried out according to clinical practice. The specific type, usage, dosage, and frequency of the drugs will be determined by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control-revention of CINV induced by HEC chemotherapy drugs | Other | Combination Product: high antiemetic regimenOndansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily) |
| Control-Prevention of CINV induced by MEC chemotherapy drugs | Other | Combination Product: moderate antiemetic regimenOndansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) |
| Prevention of CINV induced by HEC chemotherapy drugs | Experimental | Drug: Medroxyprogesterone acetate oral suspension, Combination Product: high antiemetic regimen |
| Prevention of CINV induced by MEC chemotherapy drugs | Experimental | Drug: Medroxyprogesterone acetate oral suspension, Combination Product: moderate antiemetic regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged ≥ 18 years, regardless of gender;
- Histologically or cytologically confirmed malignant solid tumor;
- No prior exposure to any chemotherapy drugs (antitumor drugs not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not considered as chemotherapy);
- Initially planned to receive single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs;
- Expected survival period ≥ 6 months;
Key exclusion criteria (20 listed)
- Having received abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy within 7 days before enrollment, or planning to receive such radiotherapy within days 1 to 8 of treatment;
- Planning to receive other moderate to high emetogenic chemotherapy drugs within days 2 to 8 after the first day of chemotherapy;
- Planning to receive chemotherapy regimens including conventional paclitaxel (using castor oil as solvent);
- Having taken drugs with potential antiemetic effects within 2 days before enrollment: 5-HT3 receptor antagonists (e.g., ondansetron, etc.), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclizine, etc.;
- Having started treatment with benzodiazepines or opioids within 2 days before enrollment (except for triazolam, temazepam or midazolam taken alone daily);
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 |
|---|---|---|
| Medroxyprogesterone acetate oral suspensionMedroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily) | Drug | Prevention of CINV induced by HEC chemotherapy drugs, Prevention of CINV induced by MEC chemotherapy drugs |
| high antiemetic regimenOndansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily) | Combination product | Control-revention of CINV induced by HEC chemotherapy drugs, Prevention of CINV induced by HEC chemotherapy drugs |
| moderate antiemetic regimenOndansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily) | Combination product | Control-Prevention of CINV induced by MEC chemotherapy drugs, Prevention of CINV induced by MEC chemotherapy drugs |
Primary outcome
the efficacy of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting induced by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs.
Time frame: 42 days
The proportion of patients with no nausea during the entire period (Day 1 to Day 21) after the start of chemotherapy administration in the first chemotherapy cycle.
4 secondary outcomes
the safety of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting induced by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs.
Time frame: 42 days
Quality of life score assessed by FLIE scale
Time frame: 42 days
Quality of life score assessed by EORTC QLQ-C30
Time frame: 42 days
Quality of life score assessed by EQ-5D scale
Time frame: 42 days
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 15 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.
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
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 Medroxyprogesterone acetate oral suspension, high antiemetic regimen and moderate antiemetic regimen in people with Malignant Solid Tumors and Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs, run by The First Affiliated Hospital of Xinxiang Medical College 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 17 inclusion and 20 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 15 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting induced by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs. (time frame: 42 days). 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 15 Aug 2025.