| CTRI Number |
CTRI/2026/02/104755 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of sleep quality and duration of fasting in determining perioperative stress in patients who have undergone chemotherapy for breast cancer prior to surgery- A prospective observational single blind study |
|
Scientific Title of Study
|
Role of sleep quality and duration of preoperative fasting in determining perioperative stress in breast cancer patients undergoing elective onco-surgery after neoadjuvant chemotherapy- A prospective observational single blind 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 Raghav Singh Jaswal |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7018649802 |
| Fax |
|
| Email |
jaswal1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9755702644 |
| Fax |
|
| Email |
Anuj.Jain.MLN@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9755702644 |
| Fax |
|
| Email |
Anuj.Jain.MLN@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Saket Nagar,Bhopal, Madhya Pradesh, India 462020 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anesthesia, 3rd Floor, All India Institute of Medica Sciences, Bhopal |
| 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 Raghav Singh Jaswal |
All India Institute of Medical Sciences, Bhopal |
Modular OT Complex, Department of Anaesthesia, 3rd Floor, All India Institute of Medical Sciences, Bhopal
Bhopal
MADHYA PRADESH |
7833964858
jaswal1698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Bhopal Institutional Human Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Age more than 30 years and less than 65 years.
2. ASAI/II patients.
3. Patients undergoing elective breast cancer surgery following neoadjuvant chemotherapy. |
|
| ExclusionCriteria |
| Details |
1. Less than 30 years age.
2. Male breast cancer patients.
3. Patients apart from breast cancers.
4. Patient with pre-existing (before diagnosis of cancer) history of sleep disturbance or hereditary sleep disturbance.
5. Patient with advance cardio-pulmonary compromise (NYHA class 4).
6. Patients with history of psychiatric illness mainly Schizophrenia or other psychosis or neurosis.
7. Patient unable to communicate or understand the assessment tools.
8. BMI more than 30.
9. Uncontrolled diabetic and hypertensive patients.
10. Patients receiving exogenous thyroid supplements or antithyroid medications.
11. ASA grade III and IV.
12. Major blood loss during surgery- more than maximum allowable blood loss (MABL) i.e.65 ml/kg of ideal body weight.
13. Missing data on study variables.
14. Patients refusing informed consent.
15. Patients receiving medications known to interfere with hormonal response to stress (e.g. Beta blockers, steroids etc). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Serum Cortisol, CRP and RBS. |
8PM previous day
8 AM in the morning
2 hours after induction of anesthesia
24 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IVCCI as a determinant of intravascular volume status. |
8AM in the morning. |
| Sleep score of the patient |
Average reading of 3 preoperative days. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
09/03/2026 |
| 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
|
In this study we will be investigating associations between psychoneurological parameters (sleep quality), cortisol, and inflammatory markers altogether in breast cancer patients undergoing elective tumor resection surgery post neoadjuvant chemotherapy. This will help in understanding the role of sleep quality and duration of preoperative fasting in determining perioperative stress response in breast cancer patients undergoing tumor resection surgery. |