| CTRI Number |
CTRI/2020/04/024505 [Registered on: 07/04/2020] Trial Registered Prospectively |
| Last Modified On: |
26/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of salivary gland function in head and neck cancer treated with Intensity Modulated Radiotherapy (IMRT) |
|
Scientific Title of Study
|
Analysis of salivary gland function by quantitative Scintigraphy in head and neck malignancies treated with Intensity Modulated Radiotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mariya Kikali |
| Designation |
DNB Resident |
| Affiliation |
HCG Hospital |
| Address |
Department of Radiation Oncology,
8, KR Road, Sampangi Ram Nagar
Bangalore
KARNATAKA
560027
India |
| Phone |
8058305341 |
| Fax |
|
| Email |
mariyakikali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariya Kikali |
| Designation |
DNB Resident |
| Affiliation |
HCG Hospital |
| Address |
Department of Radiation Oncology,
8, KR Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
8058305341 |
| Fax |
|
| Email |
mariyakikali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariya Kikali |
| Designation |
DNB Resident |
| Affiliation |
HCG Hospital |
| Address |
Department of Radiation Oncology,
8, KR Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
8058305341 |
| Fax |
|
| Email |
mariyakikali@gmail.com |
|
|
Source of Monetary or Material Support
|
| HCG Hospital
8 KR Road
Sampangi Ram Nagar
Bengaluru |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 M S Belliappa |
HCG Hospital |
Department of Radiation oncology
8 KR Road Sampangi Ram Nagar
Bangalore
KARNATAKA |
9845209243
drb339@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG Central Ethics Committee |
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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven head and neck carcinoma.
ECOG performance status 0 to 2.
Treated with IMRT/IGRT technique with minimum dose of 60Gy.
Patients who give consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Past history of head and neck irradiation.
Initial salivary dysfunction.
Any surgical procedure impairing salivary gland function.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in functions the salivary glands- |
Post treatment after 6weeks, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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="4"
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)?
|
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Brief Summary
|
Introduction: Incidence of head and neck cancers is 19.53% in India.Radiotherapy is an important modality in treatment of Head & neck cancers as a definitive therapy or in adjuvant setting. Radiotherapy to head and neck region has variety of complications inclding salivary gland dysfunction leading to Xerostomia, and it is one of the most common side effect. Salivary scintigraphy using 99mTc- pertechnate is a simple, reproducible, and minimally invasive test for quantitative assessment of salivary gland functions. We will prospectively investigate functional alterations in major salivary glands using salivary scintigraphy in a group of patients treated with Intensity Modulated Radiotherapy for head and cancers. Aims: To correlate functional changes in major salivary glands using dynamic quantitative scintigraphy and estimate their dose–response relationship in a cohort of patients with Head and Neck cancers treated using gland sparing IMRT/IGRT techniques.
Objectives: 1. To estimate change in function of salivary glands irradiated during radiation treatment to head and neck cancers using salivary gland scintigraphy. 2. To asses dose-response relationship of salivary gland function and its recovery over that time.
Research Hypothesis: Dose-response relationship of major salivary gland function which were irradiated while treating head and neck malignancies with radiotherapy.
Materials and Methods: General workup includes general history taking, general physical examination, Complete systemic examination, local and regional lymph nodes examinaition, diagnostic work up and staging. Patient will planned and treated with IMRT/IGRT technique. Salivary Scintigraphy would be done as baseline before starting radiation therapy followed by three scans on followup after the treatement on six weeks, three months and six months.
Salivary gland scintigraphy will done with the protocol with 185 MBQ of pertechnatate administered iv and dynamic images of salivary glands acquired for 30mins. Oral lime stimulus administered at 10th minute. Salivary excretion factor (SEF) will be quantified by determining the maximal excretion activity per gland as a function of maximal uptake SEF = "Umax–Umin" /"Umax " The relative change in saliva excretion rate (ΔF) compared with the baseline before the beginning of Radiation Therapy will be calculated using the pre-RT and post-RT excretion rate as follows- ∆F=(EpostRT-EpreRT)/EpreRT
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