Analysis of Acute Adverse Drug Reactions Occurring in Day Care Chemotherapy Setting at Tertiary Care Cancer Centre

This is a prospective observational study proposed by Gopesh Soni (Tutor, Principal Investigator) and Dr. Anusha Vohra (Professor & HOD, Co-Principal Investigator) from the Department of Pharmacology, Mahatma Gandhi Medical College & Hospital, Jaipur.

Title: “Analysis of Acute Adverse Drug Reactions Occurring in Day Care Chemotherapy Setting at Tertiary Care Cancer Centre”

Purpose: To examine sudden (acute) side effects/reactions that happen during or shortly after chemotherapy given in the day-care (outpatient/same-day) unit of a specialized cancer hospital. The study focuses on how often these reactions occur, what types they are (e.g., allergic, nausea, anaphylaxis), their severity (using tools like WHO-UMC or similar scales), which chemotherapy drugs cause them most, and how they are managed/treated on the spot.

Key details:

• Study type: Prospective observational (real-time monitoring as events happen, no intervention/experiment).
• Duration: 12 months after ethics approval.
• Location: Chemotherapy day-care ward and Pharmacology Department, MGMC&H, Jaipur.
• Participants: All consenting adult (>18 years) patients receiving chemotherapy in the day-care setting (no fixed sample size; all eligible during the period).
• Exclusions: Patients with concurrent other therapies (e.g., radiotherapy), known allergies beforehand, pregnancy, severe organ issues, clinical trial drugs, etc.
• Methods: Observe and record acute ADRs during chemo sessions, assess causality, severity, patterns by drug/regimen, and management approaches. Data analyzed using basic stats (e.g., in Excel).
• Rationale: Chemotherapy drugs often cause reactions due to their toxicity; monitoring helps improve safety, reduce under-reporting, and enhance patient care in India, where ADR reporting is low.
• Ethics aspects: Includes patient information sheet, informed consent (English & Hindi), no direct risks/benefits to participants (observational only), confidentiality via codes, voluntary participation.
• No budget/drug costs involved (routine care).