Clinical Profile of Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Prospective Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- A. Proportion of patients with no emesis during the acute, delayed, and protracted periods.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All adult patients (more than 18 years) diagnosed with carcinoma undergoing HEC.
Exclusion Criteria
- •Patients with history of nausea and vomiting in last seven days prior to administration of HEC.
Outcomes
Primary Outcomes
A. Proportion of patients with no emesis during the acute, delayed, and protracted periods.
Time Frame: 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.
Time Frame: Time Frame | 24 hours | 24-120 hours | more than 120 hours
Secondary Outcomes
- A. Proportion of patients requiring rescue medications.(B. Proportion of patients with complete and major response.)
Investigators
Alok Singh
Department of Pharmacology, All India Institute of Medical Sciences Raipur, Chhattisgarh, India
