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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Medroxyprogesterone acetate oral suspension
DrugMedroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily)
high antiemetic regimen
Combination productOndansetron 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 regimen
Combination productOndansetron 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)
Treatment groups
126 Participants
are divided into 4 treatment groupsGroup A: Control-revention of CINV induced by HEC chemotherapy drugsOther 1 intervention
Group B: Control-Prevention of CINV induced by MEC chemotherapy drugsOther 1 intervention
Group C: Prevention of CINV induced by HEC chemotherapy drugsExperimental treatment 2 interventions
Group D: Prevention of CINV induced by MEC chemotherapy drugsExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
42 daysSecondary outcomes
1
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.
Time frame
42 days2
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)
Time frame
42 days3
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).
Time frame
42 days4
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.
Time frame
42 daysOther outcomes
1
Cytokine levels in blood
Levels of cytokines in blood samples, measured by detecting differences in proteomic expression from blood samples collected before medication.
Time frame
42 days2
Occurrence of nausea and vomiting after treatment
Incidence and severity of nausea and vomiting in patients after treatment, analyzed in association with proteomic factors (from pre-medication blood samples).
Time frame
42 daysSponsors and contacts
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Source ClinicalTrials.gov
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