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CTRI Number  CTRI/2020/04/024939 [Registered on: 30/04/2020] Trial Registered Prospectively
Last Modified On: 28/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluate systemic inflammatory response and nutritional status before and after chemoradiation in locally advanced upper aero digestive carcinoma patients  
Scientific Title of Study   Evaluation of systemic inflammatory response and nutritional status in patients with locally advanced upper aero digestive carcinoma before and after chemoradiation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ancy Mathew 
Designation  DNB Resident 
Affiliation  HCG Hospital 
Address  HCG Hospital, Department of Radiation Oncology 8, HCG tower 5, K R Road, Sampangi Ram nagar

Bangalore
KARNATAKA
560027
India 
Phone  9497685365  
Fax    
Email  ancyannimathew@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ancy Mathew 
Designation  DNB Resident 
Affiliation  HCG Hospital 
Address  HCG Hospital, Department of Radiation Oncology 8, HCG tower 5, K R Road, Sampangi Ram nagar


KARNATAKA
560027
India 
Phone  9497685365  
Fax    
Email  ancyannimathew@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ancy Mathew 
Designation  DNB Resident 
Affiliation  HCG Hospital 
Address  HCG Hospital, Department of Radiation Oncology 8, HCG tower 5, K R Road, Sampangi Ram nagar


KARNATAKA
560027
India 
Phone  9497685365  
Fax    
Email  ancyannimathew@gmail.com  
 
Source of Monetary or Material Support  
HCG Hospital HCG Towers 8, KR Road sampangi Ram nagar Bengaluru 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Nalini Rao  HCG Hospitals  HCG Hospital, Department of Radiation Oncology 8, HCG tower 5, K R Road, Sampangi Ram nagar
Bangalore
KARNATAKA 
9845517681

nkrao@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG Central Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Biopsy proven upper aerodigestive carcinoma
Oral cavity Ca, Oropharyngeal Ca,Hypopharyngeal Ca
Locally advanced upper aerodigestive carcinoma (stage III,IV)
Patients receiving concurrent chemoradiation with platinum based chemotherapy
 
 
ExclusionCriteria 
Details  Metastatic cancer
Naso pharyngeal Ca,Laryngeal Ca
Patients have undergone surgery for locally advanced upper aero digestive tract carcinoma
Patients who couldn’t complete chemo or radio therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Inflammatory response to the treatment  before treatment, during the treatment and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   01/05/2020 
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="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Introduction:

       Head and neck cancer is the 6th leading cancer by incidence world-wide; in which vast majority are squamous cell carcinoma of upper aero digestive tract. Oral cavity, larynx and oropharynx cancer comprises almost 90%. Major modality of treatment is surgery, chemotherapy, radiotherapy or combination of three. Alteration in immune, inflammatory and angiogenetic responses within the micro environment of upper aero digestive tract Carcinoma has a role in tumor aggressiveness and response to chemo radiation. â€¢There is an association between pre-treatment haematological inflammatory markers and outcome & side effects of treatment.  Inflammation has been proposed as a potential mechanism for fatigue in head and neck ca patients who receives radiation; through inhibitory effect on dopaminergic circuits in basal ganglia by inflammatory mediators; fatigue was significantly correlated with mucositis. Pre-treatment Total leucocyte count, Neutrophil /Lymphocyte ratio, Erythrocyte sedimentation rate, C reactive protein are useful biomarkers to predict treatment outcome and select a subgroup of patients in need of more aggressive treatment approach.

 

Rationale of the study:

        Disease progression in cancer is dependent on complex interaction between tumor and host inflammatory response.  The purpose of this study is:

1.    To study the usefulness of hematological inflammatory markers in predicting short term treatment outcome and occurrence of adverse effects.

2.    The impact of pre and post nutritional status of patients who receive chemoradiation for locally advanced cancer of upper aerodigestive tract on short term treatment outcome and toxicity

 

 

Research Hypothesis:

 

   1. Systemic inflammatory markers are objective and sensitive marker of radiation induced mucositis and for predicting the short term disease outcome .

  2. Treatment the outcome is positively correlated with nutritional status of patients with locally advanced upper aerodigestive tract carcinoma.



Aim of the study:

 

1.    To evaluate the association of serum inflammatory mediators for predicting clinical response and toxicity after chemoradiation.  

2.    To  analyse the association between nutritional status and short term treatment outcome in patients with locally advanced upper aerodigestive tract carcinoma undergoing chemoradiation.

 

Objectives:

1.      To detect association between haematological inflammatory markers and acute toxicity and short term treatment response by assessing the markers(Erythrocyte sedimentation rate, C reactive protein, Total leucocyte count, Neutrophil Lymphocyte ratio)before ,during and after treatment.

2.      To assess nutritional  status of  upper aero digestive tract cancer patients treated with chemoradiation on short term treatment outcome by comparing weight, Body mass index, Mid upper arm circumference(MUAC),Triceps skin fold thickness(TSFT ) and S.Albumin before, during and after treatment.

 

Study group:

Patients with locally advanced biopsy proven upper aero digestive tract Carcinoma planned for definitive chemoradiation.

 

Study Protocol:

1.    Patients with locally advanced upper aero digestive tract Carcinoma planned for definitive chemoradiation(EBRT to a dose of 60 to 70 Grey + cisplatin 40 mg/m2 or carboplatin) will be evaluated with;

2.    Pretreatment anthropometric and laboratory parameters and repeat on 3rd week, at the end,6 wks and 3 months after chemoradiation

3.    These patients will be clinically evaluated for mucositis based on WHO grading

4.    Response is accessed by radiological imaging modality at 3 months post-treatment

 
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