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临床试验/CTRI/2025/07/091899
CTRI/2025/07/091899尚未招募不适用

Factors Associated With Anemia In Breast Cancer Patients Undergoing Chemotherapy: A Retrospective Study

NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
450
试验地点
1
主要终点
By identifying the factors associated with anemia among breast cancer patients undergoing chemotherapy, this study is expected to offer valuable insights for refining supportive care strategies

研究概览

简要总结

INTRODUCTION

Breast cancer remains one of the most prevalent malignancies worldwide, posing a significant health burden. Following the diagnosis of breast cancer, a patient has to undergo various therapies including chemotherapy. However, this treatment is associated with several adverse effects, with anemia being a particularly concerning complication.

OBJECTIVES OF THE STUDY

To determine the proportion of anemia among breast cancer patients undergoing adjuvant chemotherapy and to identify the factors associated with anemia in these patients.

METHODOLOGY

This retrospective study will be conducted among female breast cancer patients aged above 18 years with normal hemoglobin levels before starting adjuvant chemotherapy. Details pertaing to the socio-demographic and clinical parameters of the subjects presented between January 2015 and December 2024 will be collected from their medical records. Hemoglobin values recorded at the beginning of each chemotherapy cycle will be extracted from medical records for up to a maximum of eight cycles. The lowest hemoglobin value documented during the first eight cycles of adjuvant chemotherapy will be used to determine the severity of anemia in participants.

STATISTICAL ANALYSIS

Statistical aalysis will be done using SPSS version 29.0 with a 95% confidence interval. Qualitative data will be shown as frequency and percentage, while quantitative data will be presented as mean and standard deviation. The proportion of anemia will be expressed as frequency and percentage, and factors associated with anemia will be analyzed using the chi square test. A p-value of less than 0.05 will be considered statistically significant.

OUTCOME MEASURES

By identifying the factors associated with anemia among breast cancer patients undergoing chemotherapy, this study is expected to offer valuable insights for refining supportive care strategies. The findings can help clinicians in early risk assessment and to plan interventions to improve patient outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • Female breast cancer patients, aged above 18 years, who had undergone adjuvant chemotherapy.
  • Patients with normal haemoglobin count (Greater than or equal to 12 g/dl) before initiation of first cycle of adjuvant chemotherapy.

排除标准

  • Patients who received blood transfusion within two weeks before chemotherapy
  • Patients with metastatic breast cancer
  • Patients who had underwent experimental trial of chemotherapy 4.

结局指标

主要结局

By identifying the factors associated with anemia among breast cancer patients undergoing chemotherapy, this study is expected to offer valuable insights for refining supportive care strategies

时间窗: 8 months

次要结局

  • To help clinicians in early risk assessment and to plan interventions to improve patient outcomes.(8 months)

研究者

发起方
NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Academic Institute]
责任方
Principal Investigator
主要研究者

Sakshi G

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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