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

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasms of lip, oral cavity and pharynx,

• Registration Number: CTRI/2021/06/034033
• Lead Sponsor: JIPMER

Brief Summary

Radiation causes impairment of salivary gland function characterized by alteration of the volume, consistency, and pH of the secreted saliva. Saliva changes from thin, serous, neutral pH secretions to thick, tenacious and acidic secretions leading to dry mouth, sore throat, oral discomfort or pain, altered taste, difficulty in speaking, chewing or swallowing, changes in voice quality and an increased risk of dental caries. This can ultimately lead to poor nutritional intake and weight loss. As a result, the quality of life (QoL) of the head and neck cancer survivors reduces significantly post radiation treatment. Acute radiation induced xerostomia starts in the early phases of radiation treatment, usually in the first week, characterized by a 50% to 60% decrease in salivary flow. Late radiation induced xerostomia starts around 6 weeks after completion of radiation and the salivary flow diminishes to about 20%. Sparing of the salivary glands is necessary to minimize xerostomia in head and neck cancer patients. Though sparing the parotid glands has contributed significantly to a decrease in the incidence of radiation induced xerostomia it has inconsistently translated to subjective improvements in xerostomia. Reducing the dose to the submandibular glands in patients undergoing head and neck radiotherapy can augment the effect of parotid sparing IMRT in preventing xerostomia. However, they are conventionally not spared due to the concern that target coverage to the tumour area may be compromised. In a study by Hoyne etal, it was possible to reduce the mean dose to the contralateral submandibular gland to an acceptable dose of ≤39 Gy without compromising on the target volume coverage. In our institution we routinely spare both the parotid glands. We do not purposefully make an attempt to spare the submandibular gland due to the concerns of underdosing the tumor and risking recurrence. Hence we decide to conduct 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. We are evaluating the effect of submandibular sparing on patient reported outcomes subjectively and salivary function objectively.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-06
• Study Start: 2021-11-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 110

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

• 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.
• Tumour involvement of both the submandibular glands 5.
• Pre–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 VMAT	Pre radiation as baseline and at 3 months and at 6 months

Secondary Outcome Measures

Name	Time	Method
To assess the effect of sparing the submandibular gland on salivary gland function measured objectively by measuring the unstimulated and stimulated salivary secretion by using sialometry	Pre radiation as baseline and at 3 months and at 6 months
To assess the effect of sparing the submandibular gland on salivary gland function measured objectively using salivary scintigraphy	Pre radiation as baseline and at 3 months and at 6 months
To assess the proportion of patients developing acute and late side effects of salivary gland radiation using acute and late RTOG toxicity scoring criteria	Acute RTOG toxicity after every 5 fractions of radiation and at 6 weeks post radiation
To assess the proportion of patients developing acute and late side effects of salivary gland radiation using the CTCAE version 5.0	Acute toxicity after every 5 fractions and at 6 weeks post radiation
To compare the quality of life in both arms using EORTC QOL 30 and EOTC QOL 35 questionnaire version 3.0	Pre radiation as baseline and at 3 months and at 6 months
To compare the response of the tumour to radiation in both arms, assessed by CECT head and neck 3 months post radiation using the RECIST criteria	Response assessment using PETCT scan at 3 months
To compare the locoregional control in both arms assessed by CECT head and neck 6 months’ post radiation	Locoregional recurrence will be assessed at 6 months post radiation
To assess the progression free survival and overall survival in both arms	At 6 months
To assess the dosimetric parameters of the VMAT plans in both arms	Dosimetric parameters will be analysed at the completion of study in both arms

Trial Locations

Locations (1)

Jawaharlal institute of postgraduate medical education and research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal institute of postgraduate medical education and research

🇮🇳Pondicherry, PONDICHERRY, India

Dr SHYAMA PREM S

Principal investigator

9787814215

shyamaprems1@gmail.com