| CTRI Number |
CTRI/2024/10/074740 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Understanding the role of nutrition in improving surgical outcome in patients with oral squamous cell cancer |
|
Scientific Title of Study
|
Role of preoperative nutritional intervention in improving surgical outcome in patients with oral squamous cell carcinoma A randomised 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 |
Dr Anston Gerard Angelo |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ENT Office, Room 4057, 4th Floor, Academic block, AIIMS New Delhi, Ansari Nagar East, Delhi.
South
DELHI
110029
India |
| Phone |
7077202731 |
| Fax |
|
| Email |
anston456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ENT Office, Room 4057, 4th Floor, Academic block, AIIMS New Delhi, Ansari Nagar East, Delhi.
South
DELHI
110029
India |
| Phone |
9868397461 |
| Fax |
|
| Email |
winirk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anston Gerard Angelo |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ENT Office, Room 4057, 4th Floor, Academic block, AIIMS New Delhi, Ansari Nagar East, Delhi.
South
DELHI
110029
India |
| Phone |
7077202731 |
| Fax |
|
| Email |
anston456@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi, Ansari Nagar East, Delhi, India. PIN- 110029. |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi, Ansari Nagar East, Delhi, India. PIN- 110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anston Gerard Angelo |
AIIMS New Delhi |
Department of ENT, Room 4057, 4th Floor, Academic block, AIIMS New Delhi, Ansari Nagar East, Delhi, India-110029
South
DELHI |
7077202731
anston456@gmail.com |
| Dr Anston Gerard Angelo |
National Cancer Institute |
Department of Head and Neck Surgery, Room 10, Ground floor, Academic block, National Cancer Institute NCI- AIIMS, Badsa, Jhajjar, Haryana- 124105
Jhajjar
HARYANA |
7077202731
anston456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI |
Approved |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paneer 100 grams, Mustard oil 15ml, Toned milk 250ml, Roasted kala chana powder 50g per day |
4 weeks of daily nutritional intervention before surgery |
| Comparator Agent |
Standard dietary practice |
All head and neck cancer patients are directed to Nutrition OPD for baseline calorie intake assessment and advice regarding how to optimise net calorie and protein intake ahead of the surgical stress. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants older than 18 years of age with oral squamous cell carcinoma
Participants giving informed and written consent to take part in the study
Patient should be able to eat food by mouth
Patient should have functional gastrointestinal tract
Patient should be undergoing surgery for oral squamous cell carcinoma for the first time
Patient BMI should be between 18.5 to 25.5 |
|
| ExclusionCriteria |
| Details |
Patients requiring nasogastric tube or
feeding jejunostomy or parenteral nutrition
Patients who received NACT before surgery
Patients with preoperative HbA1c more than
7.850 percentage or postoperative HbA1c more than
6.650 percentage, preoperative fasting blood sugar
more than 130.50mg per dL or postoperative
fasting blood sugar more than 148.5mg per dL
Patients diagnosed with chronic kidney
disease, nephrotic syndrome
Patients diagnosed with chronic liver disease
Patients diagnosed with any autoimmune
disorders
Patient taking high dose corticosteroids for
any condition at a dose more than 20mg
Prednisolone or equivalent for more than 2
weeks within time interval of one month
before date of surgery
Patients with urine protein 1 plus
Patients with lactose intolerance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of preoperative nutritional intervention on the incidence of surgical site infection in operated patients of oral squamous cell carcinoma using the Southampton Wound Score as compared to patients following standard dietary practice in control group |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the difference in the Host Index in patients before and after receiving the nutritional intervention
To compare postoperative Host Index value of patients in intervention group and the control group |
2 months |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
21/10/2024 |
| 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="8"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Head and neck cancers are on a rising trend both in India and globally. Despite modern advancements in treatment modalities, morbidity and mortality of oral cancer patients are still high. Role of nutrition in health is common knowledge, yet it is underrated and underutilised in hospital setups mostly due to ignorance of both patients and doctors alike. Prevalence of malnutrition in Indian population is high which is further compounded in patients with oral squamous cell carcinoma due to poor oral intake. Poor preoperative nutritional status negatively impact surgical outcome by delayed wound healing and increase risk of surgical site infection and complications. This study can help in improved counselling of oral squamous cell carcinoma patients preoperatively regarding the significance of simple, easily available, culturally appropriate nutritional intervention that can improve surgical outcome and overall survival, and move a step towards implementing the same in daily practice. |