Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: C51-C58- Malignant neoplasms of female genital organs Health Condition 3: C60-C63- Malignant neoplasms of male genital organs
Conditions
Interventions
Intervention1: Pyridoxine: Pyridoxine 40 mg twice a day for 4 days will be given to participants in the intervention arm (Arm A) along with the 4 drug anti emetic prophylaxis regimen consisting of ol
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age is greater than or equal to 18 years. 2.Diagnosed with malignancy of any stage. 3.Planned to receive the first cycle of highly emetogenic chemotherapy. 4.Chemotherapy regimens must be highly emetogenic drugs on Day 1 of the cycle and have no chemotherapy on Days 2 through 4. 5.Patients must be planned for standard anti-emetic prophylaxis with a four-drug combination. 6.ECOG performance status of 0 to 2 at the time of enrolment. 7.Negative serum or urine pregnancy test in women of childbearing potential. 8.Adequate blood counts and organ functions (within 4 weeks of chemotherapy administration). This includes: Hemoglobin greater than or equal to 7 g/dL. WBC counts: greater than or equal to 4000 per cmm or Absolute neutrophil count greater than or equal to 1500 per cmm. Platelet counts: greater than or equal to 100,000 per cmm. Total Bilirubin less than or equal to 2 times ULN. AST (SGOT) less than or equal to 3 times ULN. ALT (SGPT) less than or equal to 3 times ULN. Serum creatinine less than or equal to 2 mg/dL
Exclusion criteria
Exclusion criteria: 1.Prior radiation and/or chemotherapy for current cancer diagnosis or any other cancer in the past. 2.Use of a dose of steroid other than dexamethasone. 3.Use of a dose of dexamethasone which is higher than what is planned in this study. 4.Chronic alcoholism, as determined by the investigator. 5.Organ dysfunction which prevents safe delivery of medications. 6.Concurrent use of radiation is planned (unless planned to be started greater than or equal to 1 week after cycle 1 day 1). 7.Refusal of consent. 8.Unable to answer phone calls or cooperate with other study-related activities. 9.Use of psychotherapy and/or sedative medications that can interact with the antiemetic agents. 10.Serious intercurrent illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction. 11.Known history of brain metastatic disease or seizure disorders. 12.Use of concurrent quinolone antibiotics or amifostine. 13.Human Immunodeficiency Virus (HIV) infection and/or Anti-retroviral therapy and/or Hepatitis C Virus (HCV) infection (unless treated with an undetectable viral load). 14.Active Hepatitis B infection. 15.Patients with baseline nausea and vomiting due to underlying disease or any other cause.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| “no nausea” rates in the overall period (0-120 hours)Timepoint: 0-120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| No nausea rates in the acute (0-24 hours) & delayed (24-120 hours) periods. Control of emesis, defined as a complete response (no vomiting & no use of rescue medicines), in the acute (0-24 hours), delayed (24-120 hours), & overall (0-120 hours) periods. Severity of nausea, measured using a visual analogue scale. Complete control (CC), defined as no emetic episodes, no use of rescue medication, & no more than mild nausea (less than 3 on a VAS scale of 0-10). Adverse events attributable to the investigational product. Assessment of emesis by the Functional Living Index (FLI-E). Adherence to the regimen.Timepoint: 6 days | — |
Countries
India
Contacts
Public ContactPrasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed