Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Arm A - NK1 RA + 5HT3 RA + Dexamethasone + Olanzapine
: Dexamethasone: Day 1 onwards - 8 mg prechemotherapy daily till 2 days after chemotherapy.
Written Instructions will be given to
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of malignant disease. 2. Patients scheduled to receive multi day high emetic risk chemotherapy regimen. Majority and not all of them are enlisted below Cisplatin plus Etoposide with or without additional drugs such as Bleomycin or Ifosfamide VeIP regimen include Vinblastine, Ifosfamide, Cisplatin High-dose Ifosfamide Ifosfamide with Doxorubicin Ifosfamide with Etoposide based regimens Dacarbazine based regimens for lymphoma or sarcoma BEAM or FEAM or high dose Melphalan dose greater than or equal to 140 milligrams per square meter or high dose Cyclophosphamide Total body irradiation plus multidrug chemotherapy for stem cell transplant conditioning Carboplatin plus Etoposide Busulfan plus Cyclophosphamide for transplant Doxorubicin plus Cisplatin Docetaxel plus Cisplatin plus 5 Fluorouracil 3. Age greater than or equal to 18 years. 4. ECOG performance status should be 0 to 2. 5. Subjects must have normal organ and marrow function 6. No nausea or vomiting more than 24 hours prior to participation. 7. Negative pregnancy test done less than or equal to 7 days prior to participation, for women of childbearing potential only and as per clinician discretion. 8. Women of reproductive potential who agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. 9. Patient willing and able to comply with all study requirements including treatment and able to be followed up at regular intervals and or nature of required assessments 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Patients with severe cognitive compromise. 2.Patients with a history of CNS disease brain metastases seizure disorder etc 3. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone more than or equal to 30 days before participation or planned during protocol therapy 4. The patient has taken or received any medication with known or potential antiemetic activity within the 24 hour period prior to receiving study drugs. This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics. 5. Concurrent abdominal radiotherapy. 6. Chronic alcoholism as determined by the investigator 7. Known hypersensitivity to olanzapine. 8. Medical conditions such as uncontrolled infection including HIV, uncontrolled diabetes mellitus, or cardiac disease, which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. 9. Patients who cannot swallow oral formulations of the agents. 10. Patients unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare proportion of patients with complete response (CR) (no emetic episode and no use of rescue medications) between the two study arms in the overall periods (0-120 hours) in patients receiving multiday HEC regimen; the proportion of subjects with no vomiting, no significant nausea (scored as less than 5 on a scale of 1-100) and no use of rescue medications during 1 cycle of chemotherapy.Timepoint: Overall period 0 to 120 hours following initiation of chemotherapy during Cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare complete response (CR) (no emetic episode & no use of rescue medications) between the two study arms in the acute periods (0-24 hours post- chemotherapy) in patients receiving multiday HEC regimen; the proportion of subjects with no vomiting, no significant nausea (scored as less than 5 on a scale of 1-100) & no use of rescue medications during 1 cycle of chemotherapy.Timepoint: 0 24 hours post-chemotherapy (Cycle 1).;To compare complete response (CR) (no emetic episode & no use of rescue medications) between the two study arms in the delayed periods (24-120 hours post- chemotherapy) in patients receiving multiday HEC regimen; the proportion of subjects with no vomiting, no significant nausea (scored as less than 5 on a scale of 1-100) & no use of rescue medications during 1 cycle of chemotherapy.Timepoint: 24 120 hours post-chemotherapy (Cycle 1).;To compare tolerance & side effects with both regimens.Timepoint: From first dose of study medication until 8 days after last dose in Cycle 1;Quality of Life Assessment (FLIE Questionnaire)Timepoint: Baseline (pre-Cycle 1) Mid-cycle (Day 8 2) Before Cycle 2 | — |
Countries
India
Contacts
Public ContactDr Prabhat Bhargava
Tata Memorial Centre , Mumbai
Outcome results
None listed