Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting

NCT07124195 | Not Yet Recruiting Phase 3

• 1 other identifier: CHASE012
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Malignant Solid Tumors; Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  42 days

• Quality of life score assessed by FLIE scale

  42 days

• Quality of life score assessed by EORTC QLQ-C30

  42 days

• Quality of life score assessed by EQ-5D scale

  42 days

Other Outcomes (2)

• Cytokine levels in blood

  42 days

• Occurrence of nausea and vomiting after treatment

  42 days

Study Arms (4)

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)

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)

Combination Product: moderate antiemetic regimen

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

Interventions

Medroxyprogesterone acetate oral suspension DRUG

Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily)

Prevention of CINV induced by HEC chemotherapy drugs; Prevention of CINV induced by MEC chemotherapy drugs

high antiemetic regimen COMBINATION_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)

Control-revention of CINV induced by HEC chemotherapy drugs; Prevention of CINV induced by HEC chemotherapy drugs

moderate antiemetic regimen COMBINATION_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)

Control-Prevention of CINV induced by MEC chemotherapy drugs; Prevention of CINV induced by MEC chemotherapy drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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%;

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 15, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)