A research study to look at how methylene blue dye can help doctors find the lymph nodes in the neck for people with oral cancers.

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of other and unspecified parts of mouth,

Registration Number: CTRI/2023/07/055447

Lead Sponsor: Dr Chiranjit Mukherjee

Brief Summary: **a)** **Introduction/Background of Research Project**

The head & neck region is one of the most complex and diverse part of the body both anatomically and histologically. The term â€˜head and neck cancerâ€™ refers to the malignancies of upper aerodigestive tract including the lips, oral cavity, oropharynx, sinonasal tract (including nasopharynx), larynx, hypopharynx, and salivary glands and skin over the head and neck region. Malignancy arising in these regions are also diverse, though most commonly squamous cell carcinoma.

Though lip and oral cavity cancer consists of only 2% of total cancer incidence worldwide, in India it is far more common, with an annual incidence of approximately 10.26% of total cancer incidence among both sexes and the most common malignancy in males.

Though the etiology appears to be multifactorial, the most commonly implicated factors are tobacco and alcohol. Other factors such as immunosuppression and HPV infection are also related to oral SCC, especially in younger population. Tobacco consumption may be in the form of smoking or smokeless tobacco chewing.

The presentation may range from asymptomatic premalignant lesions (erythroplakia or leukoplakia) to extensive disease with fungating mass or facial disfigurement. The majority of patients present in a locally advanced Stage III/IV in India. An early detection and appropriate management can lead to about 80% cure rates with significantly improved quality of life and functionality.

Surgery remains the mainstay of treatment for cancers of the oral cavity for decades. In contrast, radiotherapy or multimodality treatment is instituted for mainly in advanced cases to achieve an optimal therapeutic outcome and prognosis. The primary and adjuvant therapy is dictated by the T & N stage of the disease and carefully addressing the neck is equally important as the treatment of the primary site. The surgical options for the neck are comprehensive, functional or selective neck dissection. In current scenario it is debatable whether or not early stage N0 oral cancer patients should undergo elective neck dissection.

Sentinel LN biopsy is gaining more importance as it identify occult cervical metastasis and guides elective neck dissection thus decreasing morbidity. There are several methods and agents used for SLNB. In developing country like India, SLN mapping by methylene blue dye is very much appropriate as it is low cost, less allergic and easily available. But there are very limited studies internationally and nationally which uses only blue dye. The aims of our study is to address this issue by assessing the technical feasibility and accuracy of SLN mapping in patients with node-negative oral squamous cell carcinoma using methylene blue dye only.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

Patients above 18 years of age with the ability to give consent.
Patients with histopathologically proven oral cavity carcinoma (SCC).
Patients with clinically N0 neck 4.
Patients planned for surgical treatment including neck lymph node dissection as per standard guidelines.

Exclusion Criteria

Clinically node-positive patients 2.
Previous history of head & neck irradiation 3.
Recurrent or distant metastatic oral cancer 4.
Patients with inoperable oral cavity carcinoma 5.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Identification of sentinel LN in the neck in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, is technically feasible	Intraoperative and after pathological assessment
2. Accurate identification of sentinel LN in the neck in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, with more than 90% sensitivity and specificity	Intraoperative and after pathological assessment

Secondary Outcome Measures

Name	Time	Method
Accurate identification of sentinel LN in the neck for different subsite & stages in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, with more than 90% sensitivity & specificity	Intraoperative & after pathological assessment

Trial Locations

Locations (1): Himalayan Institute of Medical Science, Swami Rama Himalayan University
🇮🇳
Dehradun, UTTARANCHAL, India
Himalayan Institute of Medical Science, Swami Rama Himalayan University
🇮🇳Dehradun, UTTARANCHAL, India
Dr Chiranjit Mukherjee
Principal investigator
8697022756
chiranjit1201@gmail.com