Clinical trial: NCT05244577
Section: Alternatives
Subsections: 10、Alternative Treatments Outside This Trial

You can also get standard medical treatment and medical management without participating in this study, namely the triple regimen of aprepitant/fosaprepitant, 5-HT3RA and dexamethasone for the prevention of nausea and vomiting caused by chemotherapy. This standard treatment regimen was used in the control group of this study. The  doctor will give you detailed instructions.  
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with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21
Clinical trial: NCT05244577
Section: Confidentiality
Subsections: 12、Confidential

Your privacy will be protected. All information related to your privacy collected by this research will be kept confidential in accordance with relevant regulations. All outgoing information about you or your health from a doctor's clinic/hospital will use a number without revealing your true identity. Your identity is also not recorded in any database, speech or article. During the  or for a period of up to 15 years after the end of the study, in addition to the  physician, the sponsor or its authorized representative, members 11
with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21 of the ethics committee and/or personnel of the health supervision agency in the home country (such as the China Food and Drug Administration) may have direct access to your medical records as required by local regulations, and they may have access to your identifying information. This check is to ensure that the study is being conducted correctly and/or to ensure the quality of the study data. Those who see records that reveal your true identity will keep your secrets. While every effort will be made to protect your privacy, absolute confidentiality cannot be guaranteed. And this does not limit the responsibility of researchers and others to protect your privacy. By signing this informed consent, you consent to the collection, acquisition, use and disclosure of your information as described above.
Clinical trial: NCT05244577
Section: Participant Responsibilities
Subsections: 5、Other Things That Require Your Cooperation:

During the research period, please follow the instructions of the research doctor to take medication, and come to the hospital for examination and visit at the agreed time. The examination includes vital signs, physical examination, blood routine, blood biochemistry, 15-lead electrocardiogram, etc. Completion of the ECOG Performance Status Scale, FLIE and HAD questionnaires, recording of episodes of vomiting or retching, use of rescue therapy, and daily assessment of nausea (VAS Scale for Nausea) in the patient diary. Blood collection for exploratory research: Before the first chemotherapy, we will collect an additional 10ml of your venous baseline blood sample to measure the concentration of substance P and 5-HT in plasma. For this blood collection, we will give you a certain nutritional subsidy, subsidy See "Research Fees" for details. During the  period (1) CYP3A4 substrates: terfenadine, cisapride, astemizole, amifostine, pimozide, etc.; (2) CYP3A4 inducers: phenytoin, carbamazepine, 6
with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21 barbiturates, rifampicin, rifabutin, Hypericum perforatum, etc.; (3) CYP3A4 strong inhibitors: clarithromycin, itraconazole, ketoconazole, etc.; (4) Chinese medicine or Chinese patent medicine. Medications that have been assessed by the study physician for use are excluded.
Clinical trial: NCT05244577
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4、Precautions:|6、Risks And Discomfort: Adverse Effects Of Drugs|Potential Risks Associated With Blood Drawing|7、Potential Benefits

In most cases, treatment and testing will be done as routinely specified in the study protocol, but additional testing will be done at any time if deemed necessary by your doctor.  
If you are participating in a study, follow your doctor's arrangements for treatment. Tell your doctor promptly if you feel any discomfort or experience any adverse reactions. If your doctor decides to stop study treatment, your doctor will discuss your next steps with you.

All medicines can cause side effects. According to clinical research needs, you will use Fosaprepitant, Ondansetron Sodium Chloride Injection, Dexamethasone Tablets, Olanzapine Tablets before and after chemotherapy. You can learn more about these medicines, including side effects, from their leaflets.  
Side effects of the study drug:
Common adverse reactions in patients treated with fosaprepitant include hiccups, constipation, decreased appetite, dizziness, fatigue, abdominal distension, dizziness, and injection site adverse reactions. Site erythema, pruritus, pain, sclerosis, and thrombophlebitis. Allergic reactions, some serious or even fatal, are always possible when taking medicines. There are other rare side effects that your doctor will explain and discuss with you. You will need to tell the study doctor about any side effects that affect you. You will be promptly informed by the study doctor of important new information that may affect your decision to continue participating in the study. Ondansetron Hydrochloride Sodium Chloride Injection is mainly used for the treatment of nausea and vomiting caused by drug chemotherapy and radiation therapy. Detailed information about the medicine can be found in the medicine leaflet. The adverse reactions may include headache, warm feeling in the head and upper abdomen, abdominal discomfort, constipation, dry mouth, rash, local reactions at the injection site, occasional bronchial asthma or allergic reactions, temporary asymptomatic elevation of aminotransferase. The above reactions are generally mild and no special treatment is required. Occasionally, ataxia, seizures, chest pain, 7
with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21 arrhythmia, hypotension, bradycardia and other rare reports have been reported. Dexamethasone: Contact your study doctor right away if you experience any of the following serious side effects: vision problems; swelling, rapid weight gain, feeling short of breath; severe depression, unusual thoughts or behavior, seizures (convulsions); Bloody or tarry stools, coughing up blood; pancreatitis (severe pain in upper abdomen radiating to back, nausea and vomiting, rapid heart rate); low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort , muscle weakness or lameness); or dangerously high blood pressure (severe headache, blurred vision, ringing in the ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeat, seizures). Less severe side effects may include: sleep problems, mood changes; acne, dry, thin, bruised or discolored skin; slow wound healing; increased sweating; headache, dizziness, spinning sensation; nausea, stomach pain, gas; muscle weakness; or changes in body shape or body fat (especially fat in the arms, legs, face, neck, breasts, and waist). Olanzapine is an atypical drug currently used to treat schizophrenia, and it is also clinically used to treat nausea and vomiting caused by chemotherapy. The most common (occurring in ≥ 1% of patients) adverse reactions of olanzapine are somnolence, weight gain, eosinophilia, increased prolactin, cholesterol, blood glucose, and triglyceride levels, diabetes, increased appetite, dizziness, akathisia, Parkinson's disease, leukopenia, neutropenia, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevation of hepatic transaminases, rash, asthenia, fatigue, fever, arthralgia, Elevated alkaline phosphatase, high gamma-glutamine, high uric acid, high creatine phosphokinase, and edema. Detailed information about the medicine can be found in the medicine leaflet. Patients have experienced these side effects in previous studies, but you may also experience other side effects that are unpredictable at this time. These side effects can be minor inconveniences or serious, but if any occur, your doctor responsible for you will be watching you closely.  
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with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21 Although treatment is effective for your disease, these side effects can still occur. The effect of the drug will be regularly assessed and treatment will be discontinued if no efficacy is observed. Your doctor can exclude you from the study if the treatment was harmful to you, or you did not follow treatment instructions, or found that you did not meet the trial requirements, or the study was cancelled. You will be notified promptly if any new information about the study drug emerges during the study that may affect your decision to continue participating in the study. If the study drug causes direct damage to your health, and is determined by a doctor or specialist to be related to the drug, the medical staff will actively give the appropriate treatment.

During the study, a small amount of blood will be drawn from a vein for testing so that the study doctor can check your health. The blood draw may cause pain at the puncture site, and there is a low risk of bruising or infection at the puncture site. Some people experience dizziness, nausea, or fainting when blood is drawn. Potential risks associated with ECG **testing** Skin redness or itching may occur at the ECG electrode patch site.

Considering the antiemetic efficacy of the olanzapine-containing quadruple regimen, after participating in this clinical study, it is possible for you to obtain better remission or control than triple therapy, but it is also possible to obtain the same efficacy as triple therapy. However, because of your participation, the research on this disease and related drugs will provide valuable experience and evidence for the treatment of such patients. Because of your positive contribution, the research collaboration group expresses its sincere gratitude to you. Thanks.  
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with   and  for and  in  with Chemotherapy V1.2,Version date:2021-10-21
Clinical trial: NCT05244577
Section: Procedures
Subsections: 2、Design Of This Trial

This study is a randomized, double-blind, placebo-controlled, phase III clinical trial. The study plans to enroll 75 patients. A crossover design method is adopted. Subjects were selected as their own control group, and the treatment sequence was randomly assigned. The two treatment sequence groups (olanzapine-placebo group and placebo-olanzapine group) were uniformly numbered and randomly assigned to the two treatment sequence groups in a 1:1 ratio. Neither you nor the study doctor can choose which treatment group you will be assigned to, nor do you and the doctor know what treatment you are receiving, and if your safety is at risk and your doctor judges you need to know what treatment you are receiving, Your doctor can find out which regimen you are receiving and plan how to manage it accordingly. Efficacy and safety evaluations will be conducted simultaneously during the treatment period. Prophylactic antiemetic regimen: Eligible enrolled patients will be randomized to receive olanzapine-placebo or placebo-olanzapine plus triple regimens of prophylactic antiemetic therapy during the first 2 courses of chemotherapy. The specific regimens are as follows:
Clinical trial: NCT05244577
Section: Withdrawal from Study
Subsections: 11、Withdraw From This Study

During the research process, according to the design of the plan, if you feel that it is not suitable for you to continue taking the drug, the doctor in charge will voluntarily explain the reason to you and suspend the drug research. Your participation in this research is completely voluntary, you have the right to choose not to participate in this research, and you have the right to withdraw at any time during the research process. Your follow-up treatment will not be affected in any way, and you can continue to receive other treatments; You will not be discriminated against or retaliated against, nor will any of your medical treatment and rights be affected. If you are about to withdraw from the study, please inform your responsible physician promptly. For your safety, he will conduct a full inspection of you. Once you choose to participate in this study, we hope that you will take your medicines on time and visit and check at the agreed time without special reasons. As a research subject, you have the following responsibilities and obligations: provide the truth about your medical history and current physical condition; tell the research doctor about any problems you have during this trial; not take restricted drugs, food, etc.; Tell the study doctor if you have recently participated in other studies, or are currently participating in other studies.