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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  
not applicable 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not appplicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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