Clinical Profile of Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- A. Proportion of patients with no emesis during the acute, delayed, and protracted periods.
研究概览
简要总结
Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of cancer treatment, affecting up to 40% of patients. Nausea and vomiting are the most feared, as well as the most common adverse effects among patients undergoing chemotherapy. Despite the development of new antiemetic agents, CINV remains an issue for many patients. Additionally, there are numerous unmet needs, such as optimizing control of non-acute forms of CINV, identifying and managing patients prone to CINV, and increasing adherence to guidelines. In an important study it was observed that the main reason for antiemetic treatment failure was underestimating the emetogenicity of chemotherapy. In turn, knowledge of and providing prophylaxis for CINV can help prevent the sequelae of unresolved CINV, such as anorexia, electrolyte disturbances, and gastric or oesophageal trauma. In addition to the physical consequences, cancer patients suffer an overall worsening of quality of life with general deterioration of physical and mental health. CINV remains the most influential factors affecting patient quality life and is an important reason for refusal to continue chemotherapeutic cycles, compromising treatment efficacy.
Considering the variable response to the treatment, the study aims to assess the response to the above-mentioned protocols [9] which are widely employed for managing CINV in patients receiving HEC. In addition, present prospective observational study will also analyze the profile of patients receiving HEC. Furthermore, the study will enable us to know about potential factors associated with complete responders. In our center, as of now we don’t have any data regarding patients receiving HEC, and their response to the protocols used to manage CINV. There is no such previous study has been done.
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
- All
入选标准
- •All adult patients (more than 18 years) diagnosed with carcinoma undergoing HEC.
排除标准
- •Patients with history of nausea and vomiting in last seven days prior to administration of HEC.
结局指标
主要结局
A. Proportion of patients with no emesis during the acute, delayed, and protracted periods.
时间窗: Time Frame | 24 hours | 24-120 hours | more than 120 hours
B. Proportion of patients with no nausea during the acute, delayed, and protracted periods.
时间窗: Time Frame | 24 hours | 24-120 hours | more than 120 hours
次要结局
- A. Proportion of patients requiring rescue medications.(B. Proportion of patients with complete and major response.)
研究者
Alok Singh
Department of Pharmacology, All India Institute of Medical Sciences Raipur, Chhattisgarh, India
