Evaluate systemic inflammatory response and nutritional status before and after chemoradiation in locally advanced upper aero digestive carcinoma patients

Not yet recruiting

Conditions: Radiation Therapy,

Registration Number: CTRI/2020/04/024939

Brief Summary: **Introduction**:

Head and neck cancer is the6th leading cancer by incidence world-wide; in which vast majorityare squamous cell carcinoma of upper aero digestive tract. Oral cavity,larynx and oropharynx cancer comprises almost 90%. Major modality oftreatment is surgery, chemotherapy, radiotherapy or combination ofthree. Alteration in immune, inflammatory and angiogenetic responseswithin the micro environment of upper aero digestive tract Carcinoma has a rolein tumor aggressiveness and response to chemo radiation. â€¢There is anassociation between pre-treatment haematological inflammatory markers andoutcome & side effects of treatment.  Inflammation has beenproposed as a potential mechanism for fatigue in head and neck ca patients whoreceives radiation; through inhibitory effect on dopaminergic circuitsin basal ganglia by inflammatory mediators; fatigue was significantlycorrelated with mucositis. Pre-treatment Total leucocyte count, Neutrophil/Lymphocyte ratio, Erythrocyte sedimentation rate, C reactive protein are usefulbiomarkers to predict treatment outcome and select a subgroup of patients inneed of more aggressive treatment approach.

**Rationale of the study:**

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

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

2.    The impact of pre and post nutritional status of patients who receivechemoradiation for locally advanced cancer of upper aerodigestive tract onshort term treatment outcome and toxicity

  **Research Hypothesis:**

1. Systemic inflammatory markers areobjective and sensitive marker of radiation induced mucositis and forpredicting the short term disease outcome .

2. Treatment theoutcome is positively correlated with nutritional status of patients withlocally advanced upper aerodigestive tract carcinoma.

**Aim of the study:**

1.   Toevaluate the association of serum inflammatory mediators for predictingclinical response and toxicity after chemoradiation.

2.   To  analyse theassociation between nutritional status and short term treatment outcome inpatients with locally advanced upper aerodigestive tract carcinoma undergoingchemoradiation.

**Objectives:**

1.     To detect association between haematological inflammatory markers andacute toxicity and short term treatment response by assessing themarkers(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 tractcancer patients treated with chemoradiation on short term treatment outcome bycomparing weight, Body mass index, Mid upper arm circumference(MUAC),Tricepsskin fold thickness(TSFT ) and S.Albumin before, during andafter treatment.

**Study group**:

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

**Study Protocol:**

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

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

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

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 37

Inclusion Criteria

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.

Exclusion Criteria

Metastatic cancer Naso pharyngeal Ca,Laryngeal Ca Patients have undergone surgery for locally advanced upper aero digestive tract carcinoma Patients who couldnâ€™t complete chemo or radio therapy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory response to the treatment	before treatment, during the treatment and after treatment

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): HCG Hospitals
🇮🇳
Bangalore, KARNATAKA, India
HCG Hospitals
🇮🇳Bangalore, KARNATAKA, India
Dr Nalini Rao
Principal investigator
9845517681
nkrao@hotmail.com