Swallowing Function in Patients With Head and Neck Cancers

Head and neck cancer (HNC) is the sixth most common cancer worldwide, accounting for 2.8% of all malignancies. The presence of tumor itself, as well as the treatment, can result in neuromuscular damage affecting any stage of the swallowing. Organ-sparing care has become more common in recent years, however, that this does not always imply functional preservation. Dysphagia and aspiration both can occur and can have complex causes. Normal swallowing has oral preparatory phase, pharyngeal phase, and the oesophageal phase, it is important to know what is the dysfunction and where. This study aim to evaluate the preoperative and postoperative swallowing function in patients with head neck cancer using electromyography (EMG) and video fluoroscopy.

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Key information

Conditions

Head Neck Cancer Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Otorhinolaryngologic Diseases Pharyngeal Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

About this study

The process of swallowing includes the conscious effort to ingest food and a subconscious or reflex effort of bolus preparation. The preparation of the bolus is referred to as the preparatory phase, the transport of the bolus from the oral cavity and pharynx to the oesophagus as the transport phase and through the oesophagus as the oesophageal transport phase. The rhythm and pattern of the swallowing mechanism is controlled by a central pattern generator located in the medulla.

The tongue plays an important role in the preparatory phase by mixing the food and moving it towards the occlusal surface of the teeth. Sensory innervation across the oral mucosa and the tone of the facial muscles help in keeping the bolus within the oral cavity and in its manipulation. The soft palate approximates to the tongue to create a glossopalatal seal which prevents premature spillage in to the pharynx, while various movements of the mandible are imperative for the adequate grinding of the bolus. The tongue then contracts from anterior to posterior pushing the bolus back into the pharynx, the whole process taking about one second. This phase involves the Vth, VIIth and XIIth cranial nerves.

The pharyngeal phase is involuntary, with sensations travelling through the IXth and Xth cranial nerves and usually lasting one second. In this phase, the soft palate closes the nasopharynx, the larynx is elevated and closed, the pharyngeal constrictors contract and the cricopharynx relaxes. The true cords, the false cords, the epiglottis and the aryepiglottic folds constrict to form a barrier of several layers preventing aspiration.

The mechanism varies and there is no gold standard test that can accurately measure this dysfunction. Most patients are investigated only when it impairs the feeding and nasal feeding tubes are required. It is not know as to how much the function preserving conservative surgeries actually preserve the function and hence, the importance of this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Histologically proven cases of primary head and neck cancers.
Head and neck cancer from stage T1 to T4a, N0 to N3, M0.
Karnofsky performance status more than 70

Exclusion criteria

Patients with neurological disease
Pregnant and lactating women
H/O any prior treatment such as Surgery, Chemotherapy, Radiotherapy Surgery for recurrent disease

Treatment and study plan

Surface Electromyography and Video fluoroscopy

Diagnostic Test

Surface EMG of three muscle groups (masseter, submental, and infrahyoid) and video fluoroscopy with Omnipaque

Primary outcomes

Swallowing dysfunction assessed by fluoroscopy and EMG

Time frame: 6-8 weeks after surgery

Aspiration is defined as leakage of dye in airway and dysphagia defined as difficulty in swallowing or hold up of contrast

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Registry information

Official study title

Assessment of Swallowing Function in Patients With Head and Neck Cancer Using Surface Electromyography and Video Fluoroscopy

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 27, 2023
Registry last updated: Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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