| 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
|
|
|
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
|
|
|
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. |