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CTRI Number  CTRI/2024/11/076419 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A Study of clinical profiles of patients receiving high-emetogenic cancer chemotherapy. 
Scientific Title of Study   Clinical Profile of Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Prospective Observational Study. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alok Singh 
Designation  Associate Professor 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences Raipur, Chhattisgarh, India 
Address  Department of Pharmacology All India Institute of Medical Sciences Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9651315656  
Fax    
Email  draloksingh@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Alok Singh 
Designation  Associate Professor 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India 
Address  Department of Pharmacology All India Institute of Medical Sciences Raipur


CHHATTISGARH
492099
India 
Phone  9651315656  
Fax    
Email  draloksingh@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Alok Singh 
Designation  Associate Professor 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences Raipur, Chhattisgarh, India 
Address  Department of Pharmacology All India Institute of Medical Sciences Raipur


CHHATTISGARH
492099
India 
Phone  9651315656  
Fax    
Email  draloksingh@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur, Chhattisgarh, India 
 
Primary Sponsor  
Name  AIIMS RAIPUR 
Address  AIIMS RAIPUR TATIBANDH RAIPUR CG 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Singh  AIIMS RAIPUR  Department of Pharmacology All India Institute of Medical Sciences Raipur
Raipur
CHHATTISGARH 
9651315656

draloksingh@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients (more than 18 years) diagnosed with carcinoma undergoing HEC. 
 
ExclusionCriteria 
Details  Patients with history of nausea and vomiting in last seven days prior to administration of HEC. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A. Proportion of patients with no emesis during the acute, delayed, and protracted periods.
B. Proportion of patients with no nausea during the acute, delayed, and protracted periods.
 
Time Frame
24 hours
24-120 hours
more than 120 hours 
 
Secondary Outcome  
Outcome  TimePoints 
A. Proportion of patients requiring rescue medications.
B. Proportion of patients with complete and major response.
 
5 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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