Efficacy and Safety of Low-Dose Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Platinum-Based and AC-T Regimens: A Prospective Observational Study

Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) is a prevalent and distressing side effect experienced by cancer patients undergoing platinum-based and AC-T chemotherapy regimens. Despite advancements in antiemetic strategies, a substantial proportion of patients continue to experience inadequate control of CINV, leading to compromised quality of life and treatment compliance. Objective: To evaluate the efficacy and safe ty of low-dose olanzapine, when administered alongside standard antiemetic therapy, in preventing both acute and delayed phases of CINV. Methods: A prospective, randomized, controlled observational cohort study was conducted at the Department of Oncology, Government General Hospital, Guntur, India, from February 2024 to April 2024. Eighty eligible patients were randomized into two groups: standard antiemetics alone (n=40) and standard antiemetics with low-dose olanzapine (5 mg daily) (n=40). Incidence and severity of CINV were assessed during acute (0–24 h) and delayed (24–120 h) phases. Results: The addition of low-dose olanzapine significantly reduced both incidence and severity of acute and delayed CINV compared to control (p<0.05). A higher proportion of patients in the olanzapine group achieved complete response (no emesis, no rescue medication). Adverse events were mild and comparable between groups. Conclusion: Low-dose olanzapine is an effective and well-tolerated adjunct for CINV prevention in platinum-based and AC-T regimens. These results support its inclusion in standard antiemetic protocols.

Keywords

Introduction

Figure :1 Pathophysiology of chemotherapy-induced nausea and vomiting (CINV)

Figure 2:  Moa of Olanzapine

MATERIALS AND METHODS

Study Design: This prospective observational cohort study evaluated the efficacy and safety of low-dose olanzapine for CINV prevention.

Study Site and Duration: Conducted in the Department of Oncology, Government General Hospital, Guntur, India, from February 2024 to April 2024.

Participants: Eighty adult patients (≥25 years) scheduled for platinum-based or AC-T regimen chemotherapy were enrolled after written informed consent. Exclusion criteria included hypersensitivity to olanzapine, significant hepatic/renal/cardiac impairment, pregnancy, and concurrent interacting medications.

Randomisation And Intervention: Patients were randomized into two groups (n=40 each):
- Control: Standard antiemetic therapy (5-HT3 antagonist + dexamethasone ± NK-1 antagonist)
- Test: Standard therapy + olanzapine 5 mg orally once daily from one day prior to chemotherapy through four days post-chemotherapy.

Outcomes: Primary endpoints were incidence and severity of acute (0–24 h) and delayed (24–120 h) CINV. Secondary outcomes included complete response rates and adverse events.

Data Collection: Demographics, chemotherapy details, and CINV assessments were recorded using profile forms and the MANE scale. Adverse events were monitored.

Statistical Analysis: Data were analyzed using SPSS. Within-group comparisons employed paired t-tests; between-group comparisons used independent t-tests on change scores. A p-value <0.05 was considered statistically significant.

RESULTS

Baseline Characteristics: The two groups were comparable in age (mean ± SD: 52.4 ± 11.2 vs. 51.8 ± 10.7 years), gender distribution (M/F: 12/28 vs. 10/30), and diagnosis/regimens.
Paired t-test analyses demonstrated significant reductions in nausea scores in both drug (mean change -2.62; t=21.35; p=7.91×10?²?) and no-drug groups (mean change -1.24; t=13.00; p=3.93×10?¹?). Vomiting scores also decreased significantly (drug: mean change -2.43; t=19.80; p<0.001; no drug: -1.28; t=12.11; p<0.001). Independent t-test on change scores confirmed superior improvement in the olanzapine group for both nausea (t=-8.89; p=1.18×10?¹³) and vomiting (t=-7.45; p<0.001).

Table 1. Baseline Demographics of the Study Participants

Parameter	Drug Group (n=40)	No Drug Group (n=40)
Age (Mean ± SD)	52.4 ± 11.2	51.8 ± 10.7
Gender (M/F)	12 / 28	10 / 30
Diagnosis	Breast, GI, Lung	Breast, GI, Lung
Chemotherapy Regimen	Platinum-based, AC-T	Platinum-based, AC-T

Table 2. Nausea – Paired Sample Statistics

Group	Mean Before	SD Before	Mean After	SD After
Drug Group	3.00	0.45	0.38	0.22
No Drug Group	3.02	0.48	1.79	0.57

Table 3. Nausea – Paired Sample Correlation

Group	Correlation (r)	Sig. (2-tailed)
Drug Group	0.77	<0.001
No Drug Group	0.68	<0.001

Table 4. Nausea – Paired Samples T-Test Results

Group	Mean Difference	t-statistic	df	p-value
Drug Group	-2.62	21.35	39	7.91×10?²?
No Drug Group	-1.24	13.00	39	3.93×10?¹?

Table 5. Vomiting – Paired Sample Statistics

Group	Mean Before	SD Before	Mean After	SD After
Drug Group	2.85	0.51	0.42	0.27
No Drug Group	2.91	0.49	1.63	0.61

Table 6. Vomiting – Paired Sample Correlation

Group	Correlation (r)	Sig. (2-tailed)
Drug Group	0.81	<0.001
No Drug Group	0.70	<0.001

Table 7. Vomiting – Paired Samples T-Test Results

Group	Mean Difference	t-statistic	df	p-value
Drug Group	-2.43	19.80	39	<0.001
No Drug Group	-1.28	12.11	39	<0.001

Figure 3: Comparison Of Vomiting (Before Vs After)

Figure 4: Comparison of Nausea (Before Vs After)

X Axis- Patients     Y Axis- Nausea Grades

Figure 5: Graph For Patients and Response with And Without Drug

CONCLUSION

The present study provides compelling evidence supporting the clinical utility of low-dose olanzapine in combination with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting. Olanzapine significantly reduced both acute and delayed CINV without increasing adverse events, suggesting its value as an adjunctive agent in oncology practice. Future multicenter randomized trials are recommended to confirm these findings and optimize dosing strategies.

ACKNOWLEDGEMENTS

We extend our sincere gratitude to Dr. T.V. Siva Rama Krishna and Dr. D. Krishna Priyanka for their guidance. We thank the Principal and staff of Hindu College of Pharmacy and the administration of Government General Hospital, Guntur, for logistical support. Finally, our appreciation goes to the patients and their families for their participation.

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