| CTRI Number |
CTRI/2026/02/103544 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
22/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effects of intermittent Oxygen therapy on immature red blood cells in head and neck cancer patients |
|
Scientific Title of Study
|
Evaluating the effects of Perioperative hyperoxic intermittent stimuli on reticulocyte levels in head and neck cancer patients: a Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muralidhara P |
| Designation |
DM-Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Oncoanesthesia and Palliative medicine, Dr BRA institute rotary cancer hospital, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8553134764 |
| Fax |
|
| Email |
mdr1205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brajesh kumar Ratre |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Oncoanesthesia and Palliative medicine, Dr BRA institute rotary cancer hospital, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brajesh kumar Ratre |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Oncoanesthesia and Palliative medicine, Dr BRA institute rotary cancer hospital, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRA institute rotary cancer hospital, AIIMS, Ansari Nagar East, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| 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 MURALIDHARA P |
All India Institute Of Medical Sciences New Delhi |
Dr. B. R. Ambedkar IRCH AND National Cancer Institute-AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
8553134764
mdr1205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics comitee -AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
All standard care will be given except the intermittent oxygen therapy. Reticulocyte count will be assessed on the day before surgery and postoperative day 4. The study will take place till postoperative day 4 |
| Intervention |
Normobaric Oxygen group |
Intermittent, 60% oxygen will be given for 2 hours on the day before surgery and on postoperative days 1 and 3 via venturi mask. Reticulocyte count will be assessed on the day before surgery and postoperative day 4. the study will take place till postoperative day 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The study will include adult patients (aged 18 or older) eligible for head and neck oncological surgery. |
|
| ExclusionCriteria |
| Details |
1. Severe renal insufficiency
2. Transfusion of red blood cells, plasma during the perioperative period,
3. Bleeding requiring repeated transfusions during or after surgery,
4. Severe respiratory syndrome necessitating continuous oxygen,
5. Intolerance to an oxygen mask.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in reticulocyte count from baseline to day 4 within each group. |
1 day before surgery and on postop day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematocrit levels measured at baseline and on day 4. |
1 day before surgery and on postop day 4 |
| Hemoglobin levels measured at baseline and on day 4 |
1 day before surgery and on postop day 4 |
| Neutophil-lymphocyte ratio measured at baseline and on day 4 |
1 day before surgery and on postop day 4 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
21/02/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Anemia is a reduction in hemoglobin or hematocrit or RBC count. In cancer
patients it is more common in the peri-op period. It can warrant a blood
transfusion, which has its own side effects.
The etiology
of anemia in cancer patients is multifactorial. Erythropoietin is a hormone
secreted in response to low partial pressure of oxygen and low hemoglobin levels.
Recombinant erythropoietin and the normobaric oxygen paradox are two such interventions to prevent
and treat anemia.
Normobaric
oxygen paradox is hypothesized to increase EPO production. NOP involves
intermittent exposure to higher oxygen levels at normal atmospheric pressure. NOP has been shown to be effective in enhancing
the hemoglobin levels by increasing reticulocyte counts in non-anemic healthy
volunteers.
The frequency,
duration, timing, interval of hyperoxia and normoxia that elicit this
mechanism are still debated. The strength of oxygen is also still unclear.
Also, the neutrophil-to-lymphocyte
ratio is a biomarker of inflammation status. An elevated NLR is associated with poorer
prognosis in cancer patients.
This
study will be conducted to evaluate whether NOP mechanism can increase
reticulocyte count, thus indicating increased EPO production in head and neck
cancer patients undergoing surgeries. In addition, we also would like to
evaluate NLR trends in the preop and post surgery in cancer patients |