A single blind randomised controlled trial comparing submandibular gland plus parotid sparing versus parotid sparing alone using volumetric modulated arc therapy in patients with head and neck cancer squamous cell carcinomas
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2021/06/034033
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1. Patients with previous history of radiotherapy to head and neck
2. Patients with T1N0M0 carcinoma glottis
3. Patients with carcinoma of the head and
neck in whom the submandibular glands are enclosed completely in the clinical target volume.
4. Tumour involvement of both the submandibular glands
5. Preâ??existing salivary gland disease
6. Previous or concurrent illness that would
compromise completion of treatment or
follow-up
7. Patient receiving prophylactic amifostine or pilocarpine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of sparing the submandibular gland on patient reported outcomes measured subjectively using xerostomia questionnaire XQ in head and neck cancer patients receiving Submandibular and Parotid sparing versus Parotid sparing using Volumetric modulated arc therapy VMATTimepoint: Pre radiation as baseline and at 3 months and at 6 months
- Secondary Outcome Measures
Name Time Method