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
|
|
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
|
|
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. •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 |