Analysis of salivary gland function in head and neck cancer treated with Intensity Modulated Radiotherapy (IMRT)

Not yet recruiting

• Conditions: Radiation Therapy,

• Registration Number: CTRI/2020/04/024505

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-05
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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.

Exclusion Criteria

• Past history of head and neck irradiation.
• Initial salivary dysfunction.
• Any surgical procedure impairing salivary gland function.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in functions the salivary glands-	Post treatment after 6weeks, 3rd month and 6th month

Trial Locations

Locations (1)

HCG Hospital; 🇮🇳 Bangalore, KARNATAKA, India

HCG Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr M S Belliappa

Principal investigator

9845209243

drb339@gmail.com