Evaluation of salivary gland function before and after salivary gland sparing radiotherapy in head-neck cancers.

Phase 3

• Conditions: Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

• Registration Number: CTRI/2022/06/043364
• Lead Sponsor: Jawaharlal institute of Postgraduate Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients over 18 years of age

2. Patients with ECOG performance status 0 - 2

3. Patients of squamous cell carcinoma of the head and neck planned for radical radiation with or without concurrent chemotherapy treated with volumetric modulated arc radiotherapy

Exclusion Criteria

1. Patients with previous history of radiotherapy to head and neck

2. Patients with carcinoma of the head and neck in whom the submandibular glands are enclosed completely in the clinical target volume.

3. Tumour involvement of both the submandibular glands

4. Preâ??existing salivary gland disease

5. Previous or concurrent illness that would compromise completion of treatment or follow-up

6. Patient receiving prophylactic amifostine or pilocarpine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.Timepoint: To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.