Swallowing Function in Patients With Head and Neck Cancers

Sponsor
Banaras Hindu University (Other)
Overall Status
Completed
CT.gov ID
NCT05833841
Collaborator
(none)
50
1
1
22.4
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Surface Electromyography and Video fluoroscopy
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Swallowing Function in Patients With Head and Neck Cancer Using Surface Electromyography and Video Fluoroscopy
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Mar 15, 2023
Actual Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Evaluation of swallowing function

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

Outcome Measures

Primary Outcome Measures

  1. Swallowing dysfunction assessed by fluoroscopy and EMG [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banaras Hindu University Varanasi UP India 221005

Sponsors and Collaborators

  • Banaras Hindu University

Investigators

  • Principal Investigator: Manoj Pandey, Banaras Hindu University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Manoj Pandey, Professor, Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT05833841
Other Study ID Numbers:
  • HNQOL1
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Manoj Pandey, Professor, Banaras Hindu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023