| CTRI Number |
CTRI/2021/03/031905 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Nutrition in oral cancer patients undergoing surgery |
|
Scientific Title of Study
|
Nutritional assessment in Oral cancer patients and nutritional factors associated for postop morbidity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aseem Mishra |
| Designation |
Associate Professor Head and Neck Surgical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer centre, Varanasi |
| Address |
OPD No 27, Department of Surgical Oncology, Mahamana pandit madan Mohan Malviya cancer centre, Sunderbagiya, BHU
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8080611946 |
| Fax |
|
| Email |
draseemmishra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Aseem Mishra |
| Designation |
Associate Professor Head and Neck Surgical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer centre, Varanasi |
| Address |
OPD No 27, Department of Surgical Oncology, Mahamana pandit madan Mohan Malviya cancer centre, Sunderbagiya, BHU
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8080611946 |
| Fax |
|
| Email |
draseemmishra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aseem Mishra |
| Designation |
Associate Professor Head and Neck Surgical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer centre, Varanasi |
| Address |
OPD No 27, Department of Surgical Oncology, Mahamana pandit madan Mohan Malviya cancer centre, Sunderbagiya, BHU
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8080611946 |
| Fax |
|
| Email |
draseemmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not appplicable] |
|
|
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 Aseem Mishra |
OPD 27 Dept of surgical oncology Head & neck DMG MPMMCC |
Sundar Bagiya, Near Nariya Gate
Banaras Hindu University Campus Varanasi UTTAR PRADESH |
915422575034
draseemmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MPMMCC & HBCH, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with oral squamous cell cancer between 18 to 70 Years and planned for curative intent of treatment in form of surgery. |
|
| ExclusionCriteria |
| Details |
1.Tumour other than Squamous cell carcinoma
2.Patients receiving any treatment before presenting to the hospital.
3.Patients more than 70 and less than 18 years of age
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post op hospital stay
Post op morbidity |
1-3 days
7 days
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wound complications
Surgical risk |
28 days |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2021 |
| Date of Study Completion (India) |
14/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/05/2022 |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Progress report.
Aim/Objectives –
To assess nutritional status
among patients with Oral cancer and to know the nutritional factors responsible
for post op morbidity.
Methodology-
This was a prospective
observational study. A total of 100 patients fulfilling the inclusion criteria
i.e. Patient diagnosed with oral squamous cell cancer between 18 to 70 Years
and planned for curative intent of treatment in form of surgery were included
in the study after obtaining the informed consent form. The clinical,
Nutritional, laboratory and physical parameters were evaluated. The physical
parameters analysed in the study were Performance status, Percentage of body
weight loss, Body mass index (BMI), triceps skin fold thickness (TST), mid-arm
circumference (MAC). Laboratory parameters considered were Haemoglobin %,
haematocrit, RBC count and total leucocyte count (TLC), Serum albumin, Serum
Total Protein, Serum Urea, serum uric acid, serum AST & ALT.
Nutritional parameters were calculated like Prognostic Nutritional Index We
also calculated Nutritional Risk Index(NRI). In addition patients were assessed
for comorbidities of patient using the preoperative ASA grade, the Charlson’s
comorbidity index score and the risk of post-surgical complications were
estimated using the ACS-NSQIP risk calculator. Also, using the FRAIL scale the
frailty index was recorded in nominal scale preoperatively and postoperatively
after 28 days of surgery. Duration of hospital stay postoperatively,
intraoperative blood loss and type of reconstruction were also evaluated. The
post-surgical morbidity were graded using Clavein dindo’s morbidity grades
after 7 and 28 days postoperatively. The post-operative morbidity was recorded
as early (7days) as well as late (28 days) complication encountered in our
study. The correlation was done for the nutritional status directly affecting
morbidity and was also analysed for any indirect correlation. Comorbidities
frailty index and surgical risk index calculator used to predict the
correlation of morbidity with the above factors. All the data collected and analyzed
by using IBM SPSS version 25.
Results
In our study the overall morbidity was 33%. Out of that 17 % has
early and 16 % has late morbidity. Further classifying these into Clavein Dindo grade, in the early
post operative period, 10 % has lower
grade of morbidity where as 7 % has
higher grade of morbidity. While, in the late post operative period 13 %
has lower grade of morbidity where as 3 % has
higher grade of morbidity. Physical parameters like
weight, BMI, body weight loss, triceps skin fold thickness on POD 28 is
statistically significant for calculating PostOp Morbidity Late. Laboratory parameters like hemoglobin
POD 28, RBC POD 28, Sr. albumin POD 28, Sr. AST POD28 is statistically
significant for calculating PostOp Morbidity Late and RBC POD 7, TLC POD 1, Sr
Albumin POD1, Sr. uric acid POD 7 is statistically significant for calculating
PostOp Morbidity Early. Nutritional parameters like
NRI POD28, PNI POD 1, PNI POD 28 is statistically significant for calculating
PostOp Morbidity Late. It is found that ‘IntraOp
Blood Loss’, ‘Reconstruction’, Total Protein’ is not statistically significant
for calculating PostOp Morbidity and Clavien Dindo Grade. Conclusion The comprehensive nutritional problems experienced by patients
with Head and Neck cancers require early nutritional assessments and improved
individually tailored nutritional support. Effective nutritional risk assessment measures can be adopted
according to the research data to improve quality of life of Head and Neck
cancer patients This is a prospective observational study. Further
interventional studies can be done to formulate guidelines for nutritional
intervention among patients with Head and Neck cancer, in order to reduce
morbidity and improve quality of life.
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