An interventional study of Surface Electromyography and Video fluoroscopy in Head Neck Cancer and Oral Cancer, sponsored by Banaras Hindu University. Completed at 1 site in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Banaras Hindu University · Not applicable, Interventional, and Diagnostic
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 50 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Banaras Hindu University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Measurement of swallowing function using Surface Electromyography and video flouroscopy
Diagnostic Test: Surface Electromyography and Video fluoroscopy
Surface EMG of three muscle groups (masseter, submental, and infrahyoid) and video fluoroscopy with Omnipaque
Swallowing dysfunction assessed by fluoroscopy and EMG
Aspiration is defined as leakage of dye in airway and dysphagia defined as difficulty in swallowing or hold up of contrast
Time frame: 6-8 weeks after surgery
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Banaras Hindu University