A Prospective Observational Study for Assessment of Chemotherapy-Induced Adverse Drug Reactions in Cancer Patients

A prospective observational study was carried out to evaluate the patterns, severity, and management of chemotherapy-induced adverse drug reactions (ADRs) in cancer patients. The study included 135 patients receiving chemotherapy at a tertiary care hospital over six months. ADRs were assessed using Naranjo's causality assessment scale, Hartwig's severity scale, and Schumock and Thornton preventability criteria. The mean age of patients was 49.31 ± 12.69 years, with females (63%) experiencing more ADRs than males (37%). Breast cancer was the most prevalent malignancy (34.8%), followed by ovarian and cervical cancers in females, while lung cancer predominated in males. The most frequent ADRs were alopecia, nausea and vomiting, loss of appetite, peripheral neuropathy, and skin/nail pigmentation changes. Gastrointestinal and dermatological reactions were the most commonly affected organ systems. Naranjo's algorithm revealed 76% probable, 20% possible, and 4% definite causality relationships. According to Hartwig's scale, 58.03% ADRs were mild and 41.6% moderate in severity. The Schumock and Thornton criteria classified 62% of reactions as definitely preventable. Statistical analysis showed no significant association between ADR severity and patient age (p=0.73) or gender (p=0.45). Notably, myelosuppression persisted despite dose adjustments, and emesis remained poorly controlled despite prophylactic antiemetic therapy. The study shows the need for enhanced pharmacovigilance and personalized approaches to minimize chemotherapy-induced ADRs.

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Journal
Journal of Pharma Insights and Research.
Published
2025-04-05
DOI
https://doi.org/10.69613/5qhybf06
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
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article
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article

A Prospective Observational Study for Assessment of Chemotherapy-Induced Adverse Drug Reactions in Cancer Patients

Govinda Rao Kamala, K.A. Sunitha, Ravi Prakash Degala, Ramya Sri Bura et al.
Journal of Pharma Insights and Research.
Pharmacovigilance and Adverse Drug Reactions
article

A Prospective Observational Study for Assessment of Chemotherapy-Induced Adverse Drug Reactions in Cancer Patients

Govinda Rao Kamala, K.A. Sunitha, Ravi Prakash Degala, Ramya Sri Bura, Sujatha Gorle, Nagalaxmi Pinnamraju
article en

Abstract

A prospective observational study was carried out to evaluate the patterns, severity, and management of chemotherapy-induced adverse drug reactions (ADRs) in cancer patients. The study included 135 patients receiving chemotherapy at a tertiary care hospital over six months. ADRs were assessed using Naranjo's causality assessment scale, Hartwig's severity scale, and Schumock and Thornton preventability criteria. The mean age of patients was 49.31 ± 12.69 years, with females (63%) experiencing more ADRs than males (37%). Breast cancer was the most prevalent malignancy (34.8%), followed by ovarian and cervical cancers in females, while lung cancer predominated in males. The most frequent ADRs were alopecia, nausea and vomiting, loss of appetite, peripheral neuropathy, and skin/nail pigmentation changes. Gastrointestinal and dermatological reactions were the most commonly affected organ systems. Naranjo's algorithm revealed 76% probable, 20% possible, and 4% definite causality relationships. According to Hartwig's scale, 58.03% ADRs were mild and 41.6% moderate in severity. The Schumock and Thornton criteria classified 62% of reactions as definitely preventable. Statistical analysis showed no significant association between ADR severity and patient age (p=0.73) or gender (p=0.45). Notably, myelosuppression persisted despite dose adjustments, and emesis remained poorly controlled despite prophylactic antiemetic therapy. The study shows the need for enhanced pharmacovigilance and personalized approaches to minimize chemotherapy-induced ADRs.

Journal of Pharma Insights and Research.Vol. 3(2)
Tatyasaheb Kore Dental College and Research Centre (IN), Hindu College of Pharmacy (IN)
Openalex Percentile: Top 93%
Pharmacovigilance and Adverse Drug Reactions
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A Prospective Observational Study for Assessment of Chemotherapy-Induced Adverse Drug Reactions in Cancer Patients — Govinda Rao Kamala, K.A. Sunitha, et al. · Journal of Pharma Insights and Research. (2025) | TGRS Research Map | TGRS