Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: Capsule THC/CBD: Arm A Day 0 (1 day before chemotherapy)
Cap THC/CBD three times at 4 hourly intervals
Day 1
60 mins before chemotherapy,
capsule aprepitant 125 mg PO plus
Palonosetron
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients has a confirmed diagnosis of cancer and is receiving one of the mentioned chemo-therapy protocols mentioned previously. 2)The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. -The patient is aged > 18 years. a) Patients should be chemotherapy naive b)The patient has a WHO Performance Status of 3) Total neutrophils >= 1500/mm3 Platelets >= 100,000/mm3 Bilirubin = 50 ml/min 4)The patient is able to read, understand, and complete questionnaires and daily compo-nents of the Patient Diary for each study cycle. 5) For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening. 6) Has a normal baseline ECG with QTc prolongation
Exclusion criteria
Exclusion criteria: 1) The patient is unable to read, understand, and complete the forms required for the study. 2) The patient is pregnant (serum pregnancy test) or lactating. 3) The patient has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication. 4) The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient. 5) The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or THC/CBD 6) The patient has received an investigational drug in the previous 6 months or is scheduled to receive any investigational drug other than fosaprepitant dimeglumine during the study period 7) The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications. Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication. 8) The patient has taken/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 9) Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors. This will have to be evaluated for and decision taken by PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of interest between the two arms of antiemetics is the complete response (CR) rates post 1st cycle of chemotherapy. This is the basis for statistical considerations as men-tioned above.Timepoint: 54 month | — |
Secondary
| Measure | Time frame |
|---|---|
| -â??No emesis ratesâ?? between the 2 arms for cycle 1 individually -No significant nausea rates between the 2 arms for cycle 1 individually -QOL comparisons using FLIE questionnaire between the 2 arms -To compare tolerance and side effects with both regimens Timepoint: 54 month | — |
Countries
India
Contacts
Public Contactvikas ostwal
Tata Memorial Hospital
Outcome results
None listed