| CTRI Number |
CTRI/2024/06/069352 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A preliminary study investigating how a blood marker(betahydroxybutyrate) is affected by chemotherapy in breast cancer patients |
|
Scientific Title of Study
|
Role of serum Beta Hydroxy Butyrate levels in Doxorubicin and Cyclophosphamide induced neutropenia in breast cancer patients: A Pilot 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 N.P.K.Teja |
| Designation |
DM-student (Senior Resident) |
| Affiliation |
AIIMS Rishikesh |
| Address |
Dr.N.P.K.Teja,
Senior Resident,
Department of Pharmacology,
All India Institute of Medical Sciences (AIIMS),
Rishikesh,
Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7095453516 |
| Fax |
|
| Email |
TEJADMCPAIIMS@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Puneet Dhamija |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Dr.Puneet Dhamija,
Professor,
Department of Pharmacology,
All India Institute of Medical Sciences (AIIMS),
Rishikesh,
Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000292 |
| Fax |
|
| Email |
puneet.phar@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.N.P.K.Teja |
| Designation |
DM-student (Senior Resident) |
| Affiliation |
AIIMS Rishikesh |
| Address |
Dr.N.P.K.Teja
Senior Resident,
Department of Pharmacology,
AIIMS Rishikesh,
Rishikesh,
Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7095453516 |
| Fax |
|
| Email |
TEJADMCPAIIMS@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,
Virbhadra Road,
Rishikesh,
Uttarakhand,
India.
Pincode: 249203 |
|
|
Primary Sponsor
|
| Name |
DrNPKTeja Self |
| Address |
Dr.N.P.K.Teja,
Senior Resident,
Department of Pharmacology,
All India Institute of Medical Sciences(AIIMS),Rishikesh,Uttarakhand.
Pincode: 249203 |
| Type of Sponsor |
Other [student-self sponsored] |
|
|
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 N P K Teja |
AIIMS Rishikesh |
Level-4, Department of Pharmacology,Room no.3010
Dehradun
UTTARANCHAL |
7095453516
TEJADMCPAIIMS@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee- AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who have histopathologically confirmed breast malignancy and
Fit to receive Doxorubicin and Cyclophosphamide chemotherapy
Chemotherapy naive
Age above 18 years
Participants with
a.Haemoglobin above 8gm/dl,
b.Platelet count above 1,00,000/mm3
c.Absolute neutrophil count above 1500/ mm3
Patients with Left Ventricular Ejection Fraction more than 50%.
Participants with ECOG (Eastern Co-operative Oncology Group) performance status of 0-2. |
|
| ExclusionCriteria |
| Details |
Not willing to provide informed consent
Participants with history of, use of drugs causing bone marrow toxicity like, Lamotrigine, Dapsone, Quinidine,Quinine, Propylthiouracil, Clozapine, Vancomycin in the past 2 months.
Patients with Chronic Kidney Disease with Creatinine clearance lesser than 30ml/min
Patients with Chronic hepatic disorders with Serum total Bilirubin greater than 5mg/dl and Transaminases (ALT & AST more than 5 times normal limit
Patients with refractory anaemia and with history of blood transfusions
Patients with Uncontrolled Diabetes Mellitus with HbA1c greater than or equal to 8% .
Diabetic patients receiving Insulin.
Patients who are on keto diet.
Participants with history of alcohol intake in the past 7 days.
Patients with known hypersensitivity to Doxorubicin or Cyclophosphamide. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find association between Serum Beta Hydroxy Butyrate levels and development of neutropenia after administration of Doxorubicin and Cyclophosphamide for breast cancer |
day 0, day 14 or before second cycle of chemotherapy, last day of chemotherapy of 4 to 6 cycles of chemotherapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate a cutoff level of serum Beta hydroxy butyrate levels for development of neutropenia using a ROC (Receiver Operating Characteristic) Curve, in the presence of an association between them.
Exploration of role of serum BHB levels in Doxorubicin and Cyclophosphamide chemotherapy induced cardiotoxicity. |
day 0, day 14 or before second cycle of chemotherapy, last day of chemotherapy of 4 to 6 cycles of chemotherapy. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/06/2024 |
| 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="0"
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
|
This is a prospective, observational, pilot study which aims to explore the role of Serum Beta hydroxy butyrate levels in predicting neutropenia in patients receiving Doxorubicin and Cyclophosphamide regimen in patients diagnosed with breast cancer.Aim: To explore the role of serum Beta hydroxy butyrate levels in prediction of Doxorubicin and Cyclophosphamide induced neutropenia in breast cancer patients. Objectives: Primary objective: Ø A study of correlation between serum BHB levels and development of Doxorubicin and Cyclophosphamide induced neutropenia. Secondary objective: Ø Development of an algorithm or a scoring system, in the presence of a correlation between serum BHB levels and development of neutropenia. Ø Exploration of role of serum BHB levels in other toxicities of Doxorubicin and Cyclophosphamide chemotherapy like cardiotoxicity and alopecia. sample size- 30 participants. |