Symptoms and General Pathology

All Conditions

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Postoperative Complications

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Fosaprepitant

Aprepitant

Cisplatin

Dexamethasone acetate

Ramosetron

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Serotonin

Day 1:

Aprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy

Day 2 - 3:

Aprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning

Day 4 Dexamethasone 8 mg PO. in the morning

Ramosetron, Aprepitant, Dexamethasone

Hyo Jung Kim, M.D.

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.

But until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer

A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer

Merck Sharp & Dohme LLC

Hallym University Medical Center

Neoplasms

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Emetics

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Vincristine

Ifosfamide

BB 1101

Isophosphamide mustard

Mesna

Mechlorethamine

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Arm 1, Single Dose: Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 or Day 1 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Arm 2, Two Doses: Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 or Day 1 + Day 4 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.

Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)

5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy

5HT3 receptor antagonist

Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.

Ifosfamide-based chemotherapy (AI)

25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Prior to ifosfamide (Day 1) - 500 mg/m\^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m\^2. The mesna infusion complete 24 hours after last dose of ifosfamide.

2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).

2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied.

Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Study Groups:

If you are found to be eligible to take part in this study, you will receive fosaprepitant during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to 1 of 2 study groups, each with 2 divisions:

* If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.
* If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.
* If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.
* If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.

You and the study staff will know to which group and division you are assigned. Each time you receive the drug, you will receive it by vein over about 20-30 minutes.

You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam, diphenhydramine, and promethazine). You will sign a separate consent form that will describe these treatments in detail, along with their risks.

You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent nausea and vomiting.

Before each chemotherapy cycle, you will be given a study diary. Each day, you will record any side effects you may . You should bring your study diary to every study visit so the study staff can review it.

Study Visits:

Before each cycle that you receive fosaprepitant, the following tests and procedures will be performed:

* You will have a physical exam.
* Your vital signs, weight, and performance status will be recorded.
* You will fill out the same questionnaire you did at screening.
* You will be asked about any other drugs you may be taking. Be sure to tell the study doctor about all drugs (including vitamins, herbal products, and nutritional supplements), because some drugs/substances will cause side effects when taken at the same time as fosaprepitant.
* Blood (about 5 teaspoons) will be drawn for routine tests.

Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for routine tests.

Pharmacokinetic Testing:

On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures the amount of study drug in the body at different time points. The blood will be drawn before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours after the infusion.

Length of Study:

You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You will no longer be able to take the study drug if the disease gets worse or if intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam.
* Your vital signs, weight, and performance status will be recorded.
* You will fill out the same questionnaire you did at screening.
* You will be asked about any other drugs you may be taking.
* Blood (about 5 teaspoons) will be drawn for routine tests.

This is an investigational study. Fosaprepitant is FDA approved and commercially available in combination with other drugs for the prevention of nausea and vomiting that may be caused by chemotherapy. It is investigational to study how fosaprepitant may affect the drug levels of ifosfamide in the blood and how many doses should be given.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen

Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.

M.D. Anderson Cancer Center

Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].

Control Cycle (Arm A/Arm B)

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).

Arm A: Single Dose, Day 1

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).

Arm B: Two Doses, Day 1 + Day 4

Total

Between 19 and 65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology

Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.

Complete Response

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm A: Single Dose, Group 1

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm A: Single Dose, Group 2

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm B: Two Doses, Group 1

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm B: Two Doses, Group 2

Cycle 1

Cycle 2

Skin and Connective Tissue Diseases

Chondrosarcoma

Sarcoma, Alveolar Soft Part

Neoplasms, Connective Tissue

Alveolar Soft Part Sarcoma

Antirheumatic Agents

Loperamide

Allopurinol

Antidiarrheals

Antimetabolites

Antioxidants

Protective Agents

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of chondrosarcoma.

Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of alveolar soft part sarcoma.

Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Patients with sarcoma subtype: histologically or cytologically confirmed diagnosis of extra-skeletal myxoid chondrosarcoma.

Supportive Care Guidelines for perifosine include antiemetic prophylaxis (antiemetics will be administered at the treating investigator's discretion), diarrhea management (loperamide), and hyperuricemia prophylaxis (allopurinol).

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.

Perifosine

All patients should be instructed to take loperamide at the earliest signs of diarrhea and/or abdominal cramping after beginning perifosine.

Patients with a known history of hyperuricemia and/or gout should receive prophylactic treatment with allopurinol 300 mg po daily.

Antiemetic prophylaxis will be administered at the treating investigator's discretion.

Dejka Araujo, MD

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include:

* In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas.
* Response to therapy will be based on regression of measurable disease according to Choi criteria. Time to progression and duration of stable disease will be measured as secondary endpoints of the study.

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression.

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals.

STUDY KEY POINTS

* Treatment will be administered on an outpatient basis in 28-day cycles.
* Growth factors should not be needed, however, use by patients on this trial is NOT prohibited.
* A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer.

One treatment arm: Perifosine. Three groups related to sarcoma subtype: histologically or cytologically confirmed diagnosis of (a) chondrosarcoma, (b) alveolar soft part sarcoma and (c) extra-skeletal myxoid chondrosarcoma.

A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

To investigate whether perifosine has a response rate of \> 20% in this group of patients with chemo-insensitive sarcomas.

Best response recorded from the start of the treatment until disease progression/recurrence.

Stable disease is measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started.

Sarcoma Alliance for Research through Collaboration

AEterna Zentaris

Breast Neoplasms

Breast Diseases

Skin Diseases

Herbal and Botanical

Granisetron

a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation.

At the start of skin closure, saline (3 ml) was administered i.v.

Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.

At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.

Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.

At the start of skin closure, saline (3 ml) was administered i.v.

Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)

electric stimulation therapy

Jun Zhang, PhD

Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.

186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.

Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery

the frequency and dose of postoperative antiemetics

Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery

Fudan University

Professor

Central Nervous System Depressants

Psychotropic Drugs

Cyclophosphamide

Olanzapine

Tropisetron

Antipsychotic Agents

Selective Serotonin Reuptake Inhibitors

Serotonin 5-HT3 Receptor Antagonists

Olanzapine in combination with fosaprepitant and tropisetron

Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone

fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4

Fosaprepitant , Tropisetron and Olanzapine

On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.

fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4

Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine

Zhenzhen Liu

Standard antiemetic therapy without dexamethasone for the prevention of nausea and vomiting in patients with breast cancer

This is a multicenter, randomized, controlled, open-label, phase III study assessing the efficacy and safety of fosaprepitant, tropisetron and olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy. Eligible patients will be randomized to receive either standard antiemetic therapy (fosaprepitant, tropisetron, dexamethasone and olanzapine) or standard antiemetic therapy without dexamethasone in a 1:1 ratio.

Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer

Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy

Complete response is defined as a condition in which a patient does not show vomiting or retching and does not require additional treatment with antiemetics. Retching is defined as the physical reaction that accompanies vomiting in the absence of gastric content ejection.

Complete control is defined as a condition where a patient shows no nausea or mild nausea

Total control is defined as a condition where a patient neither shows nausea nor vomiting.

No (or minimal) Impact on patient's Daily Life (NIDL) is generally considered a score ≥54 (6 points mean for each item)

Henan Cancer Hospital

Director, Head of Breast Oncology

Behaviors and Mental Disorders

Quality of Life

Acute Graft Versus Host Disease

Dermatologic Agents

Ondansetron

Palonosetron

Metoclopramide

Early emesis: Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV.

Delayed emesis: Dexamethasone 8 mg orally on days 2, 3 and 4.

Early emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV.

Delayed emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.

Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV for early emesis and for delayed emesis Dexamethasone 8 mg orally on days 2, 3 and 4.

Early emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV. and for delayed emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.

Claudia H Arce Salinas, MD

Juan P González Serrano, BD

Julieta Santamaría Galicia, BD

Nausea and vomiting are common complications on the chemotherapy (CT) and can affect the quality of life (QoL) of the patients. If not treated adequately it can produce other problems such as dehydration, weight loss, fatigue and even can induce the non-compliance of the treatment. In extreme cases it can put the patient ́s life at risk. There are various antiemetic treatments that vary both in cost and effectiveness. It ́s important to determine which are the strategies that are most effective and can improve the QoL of the patients.

Methodology:

The analysis will be done in patients who receive adjuvant and neoadjuvant chemotherapy and that have not received previously chemotherapy or radiotherapy, they will be stratified according to the emetogenic potential of the CT. They were given a diary of symptoms to register any discomfort suffered after receiving their treatment and also a quality of life questionnaire was applied previous to their first cycle and previous to their second cycle.

The patients were divided in two groups receiving either A scheme (palonosetron) or B scheme (ondansetron) in combination with dexamethasone and fosaprepitant for prevention of early emesis and Dexamethasone to group A or Dexamethasone + metoclopramide to group B for prevention of delayed emesis. As well It was analyzed the three most prevalent single nucleotide polymorphisms (SNPs) on gene ABCB1 using PCR.

The aim of this study is to evaluate the efficacy and quality of life provided by the 2 regimes noted above based on Mexican population so the results obtained can be applied widely in our country.

Nausea and vomiting are common complications on the chemotherapy (CT) and can affect the quality of life (QoL) of the patients. If not treated adequately Nausea and vomiting can produce other problems such as dehydration, weight loss, fatigue and even can induce the non-compliance of the treatment. In extreme cases it can put the patient ́s life at risk. There are various antiemetic treatments that vary both in cost and effectiveness. It ́s important to determine which are the strategies that are most effective and can improve the QoL of the patients.

Methodology:

Effectiveness and quality of life analysis of patients with breast cancer that will receive adjuvant and neoadjuvant chemotherapy highly and moderately emetic chemotherapy (adriamycin and cyclophosphamide (AC), docetaxel and carboplatin (TC), docetaxel, carboplatin and trastuzumab (THC)); there will only be consider those patients that are candidates to receive CT for the first time and should have central venous access. There will be excluded patients that had received previously any kind of chemotherapy or radiotherapy. The follow-up will exclusively be done during the first cycle of CT. Patients will be stratified according to the emetogenic potential of the CT regimen ad not by the clinical stage or the histologic type of the tumor.

To keep a follow-up of the patient there will be provided symptomatic diaries where the patient can register any discomfort suffered after receiving their treatment. Along with this, there will be applied quality of life questionnaires, one previous to the CT and one previous to the second cycle.

There a proposed two regimes on antiemetic treatment. The randomization is as follows.

Group A Early emesis: Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV Delayed emesis: Dexamethasone 8 mg orally on days 2, 3 and 4.

Group B Early Emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV Delayed Emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.

Considering the absence of at least one event of nausea and vomiting as a measure of effectiveness, it will be calculated the effectiveness ratio, as well as the QoL questionnaires before and after the first chemotherapy.

Finally, previously to the application of the treatment there will be obtained a peripheral blood sample for its analysis on translational medicine laboratory. There will be a process of extraction of Deoxyribonucleic Acid accordingly to the guides and the sample will be analyzed by a protein chain reaction (PCR) to detect the three most prevalent polymorphisms (SNPs)on gene ABCB1.

H0: There ́s no difference in cost - effectiveness ratio in antiemetic therapy (acute and delayed) between A and B schemes.

H1: Scheme A is superior than scheme B in 10 % for prevention of acute nausea and vomiting and 6% in delayed nausea and vomiting.

Applications:

The guides that are actually used for the antiemetic treatments are based in non Mexican populations. With this study it is expected to design an effective strategy that can be applied in mexican population

Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer	NCT01046461	Solid Tumour Postoperative N...	Ramosetron, Apr...	18 Years - 75 Years	Hallym University Medical Center
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen	NCT01490060	Sarcoma Chemotherapy-in... Effects of Chem... Adverse Effects...	Fosaprepitant Dexamethasone 5HT3 receptor a... Ifosfamide-base... Doxorubicin Mesna Ifosfamide Vincristine	18 Years - 65 Years	M.D. Anderson Cancer Center
A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas	NCT00401388	Chondrosarcomas Alveolar Soft P... Extra Skeletal ...	Perifosine Loperamide Allopurinol Antiemetics	13 Years -	AEterna Zentaris
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery	NCT05408676	Mammary Cancer PONV	electric stimul...	18 Years - 64 Years	Fudan University
Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer	NCT05242874	Chemotherapy-in...	Fosaprepitant ,... Fosaprepitant ,...	18 Years - 70 Years	Henan Cancer Hospital
Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer.	NCT03606369	Breast Neoplasm Antineoplastic ... Antiemetics Quality of Life	Palonosetron Ondansetron	18 Years -	Instituto Nacional de Cancerologia de Mexico
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)	NCT01636947	Nausea Vomiting	Aprepitant Aprepitant Plac... Ondansetron Dexamethasone Ondansetron Pla... Rescue Therapy ...	21 Years -	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for antiemetics

Every month we try and update this database with for antiemetics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for antiemetics

Every month we try and update this database with for antiemetics cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for antiemetics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.