| CTRI Number |
CTRI/2025/07/091835 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on How Gut Bacteria and Body Processes Influence Nausea and Vomiting Caused by Chemotherapy in Stem Cell Transplant Patients |
|
Scientific Title of Study
|
Microbial and metabolic determinants of chemotherapy induced nausea and vomiting :A systems-level multi-omics investigation into gut-derived biological pathways influencing chemotherapy induced nausea and vomiting in stem cell transplant patients-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 |
Dr Abhivandana Pallati |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Medical Oncology 2nd Floor, Dr B.R.A.I.R.C.H, AIIMS, Ansari Nagar, New Delhi 110029
Department of Medical Oncology 2nd Floor, Dr B.R.A.I.R.C.H, AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9581177050 |
| Fax |
|
| Email |
abhivandanapallati97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepam Pushpam |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room No. 245, Department of Medical Oncology, 2nd Floor, Dr B.R.A.I.R.C.H, AIIMS , Ansari Nagar, New Delhi 110029
Room No. 245, Department of Medical Oncology,2nd Floor, Dr B.R.A.I.R.C.H, AIIMS , Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepam Pushpam |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room No.245,Department of Medical Oncology 2nd Floor, Dr B.R.A.I.R.C.H, AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9650629370 |
| Fax |
|
| Email |
deepampushpam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Ansari Nagar, New Delhi 110029 |
| 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 Deepam Pushpam |
All India Institute of Medical Sciences |
Room No.245, Department of Medical Oncology 2nd Floor, Dr B.R.A.I.R.C.H, AIIMS , Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
9650629370
deepampushpam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the study and to provide written informed consent
2. Patients aged 12yrs to 65 yrs. undergoing
Conditioning for autologous or allogenic hematopoietic stem cell transplant
3. Weight more than or equal to 30 kg
|
|
| ExclusionCriteria |
| Details |
1) Hepatic dysfunction (aminotransferase/alanine aminotransferase more than 3 times of upper normal limit, serum bilirubin more than 2 times of upper normal limit)
2) Patients with cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months
3) Preexisting psychiatric disorders
4) Severe renal impairment (GFR less than 50 ml/hr. or creatinine more than 1.5 times upper normal limit)
5) Pregnant or lactating women
6) Refusal to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the association between baseline microbiome and chemotherapy induced nausea vomiting in patients undergoing hematopoietic stem cell transplant |
Baseline and at the end of 6 days from last day of conditioning regimen |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the association between the gut microbiome composition and the metabolomics profile with CINV
2. To evaluate the association between dietary intake and gut microbiome composition with CINV
3. To perform an integrative analysis to explore:
The interaction between microbiome, metabolomics, diet and their combined effect on CINV.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
05/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 continues to be a significant distressing complication in patients undergoing hematopoietic stem cell transplantation. The prevalence of break through CINV in up to half of such patients not only impairs quality of life but also affects treatment, nutritional status, recovery outcomes. Recent insights into the gut brain axis suggests that the gut microbiome plays a critical role in modulating chemotherapy related toxicities, including emetic responses. Chemotherapy disrupts the gut microbial ecosystem, alters metabolite production and promotes inflammation. All of which may influence nausea and vomiting pathways. While emerging studies in solid tumors highlight the potential link between microbiota and CINV, there is currently no data specific to the hematopoietic stem cell transplantation. Given this context, investigating the microbiome CINV relationship in these patients is both timely and necessary. This study will fill a critical knowledge gap by identifying microbiota and metabolic signatures predicting of CINV, laying the groundwork for future personalized, microbiome targeted anti emetic interventions that may ultimately improve clinical outcomes and patient well being during transplantation. |