Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIPING ZHOU
About this trial
The primary objective of this clinical study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the prophylaxis of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.
The study population consists of gastric adenocarcinoma patients who are scheduled to receive their first course of moderately emetogenic chemotherapy (PD-1/PD-L1 immune checkpoint inhibitors combined with the CAPOX regimen). This study is divided into two phases. The first phase is a single-arm study design, with the primary objective of preliminarily assessing the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the full-course management of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The second phase will adopt a randomized, controlled, multicenter trial design. Based on the efficacy and safety data from the first phase, the investigators will optimize the trial design (primarily including the primary endpoint and sample size calculation) to evaluate the efficacy and safety of nanocrystalline megestrol acetate compared with dexamethasone, each combined with a 5-HT3 receptor antagonist, for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, no gender restrictions;
Histologically or cytologically confirmed locally advanced/recurrent or metastatic gastric adenocarcinoma that is unresectable for curative treatment;
No prior exposure to any chemotherapy drugs (anticancer drugs not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not considered chemotherapy);
First-line treatment planned to include a moderately emetogenic chemotherapy agent, specifically a PD-1 inhibitor (Tislelizumab is recommended), in combination with the CAPOX chemotherapy regimen for anticancer therapy;
Disqualifiers
Received abdominal (including the diaphragmatic plane and below) or pelvic radiotherapy within 7 days prior to enrollment, or plans to receive such radiotherapy between days 1 and 8 of treatment;
Plans to administer other chemotherapy drugs with moderate to high emetogenic potential between days 2 and 8 following the first day of chemotherapy;
History of venous thromboembolic disease within the past 6 months;
Use of medications with potential antiemetic effects within 2 days prior to enrollment: 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., chlorpromazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secobarbital;
Trial design
Design model
Parallel
Treatments tested in this trial
nanocrystalline megestrol acetate combined with ondansetron
Drugnanocrystalline megestrol acetate (5 ml PO, qd, Day 1-Day 14), ondansetron (8 mg IV, qd, Day 1).
dexamethasone combined with ondansetron
Drugdexamethasone (8 mg IV, qd, Day 1), ondansetron (8 mg IV, qd, Day 1)
Treatment groups
127 Participants
are divided into 3 treatment groupsGroup A: Single-arm study groupExperimental treatment 1 intervention
Group B: nanocrystalline megestrol acetate groupExperimental treatment 1 intervention
Group C: dexamethasone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients without nausea during the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.
Time frame
the entire period (Day 1-Day 21) after the start of chemotherapy drug administration in the first chemotherapy cycle.Locations
Sponsors and contacts
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AIPING ZHOU
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Henan Cancer Hospital
Collaborator
Source ClinicalTrials.gov
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