Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xinxiang Medical College
About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.;
Trial design
Treatments tested in this trial
- Medroxyprogesterone acetate oral suspension
- high antiemetic regimen
- moderate antiemetic regimen
Treatment groups
126 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov