Swallowing Function in Patients With Head and Neck Cancers
Primary Purpose
Head Neck Cancer, Oral Cancer
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Surface Electromyography and Video fluoroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Head Neck Cancer focused on measuring Swallowing, Aspiration, Surgery, treatment, Dysphagia
Eligibility Criteria
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
Sites / Locations
- Banaras Hindu University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation of swallowing function
Arm Description
Measurement of swallowing function using Surface Electromyography and video flouroscopy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05833841
First Posted
March 21, 2023
Last Updated
April 18, 2023
Sponsor
Banaras Hindu University
1. Study Identification
Unique Protocol Identification Number
NCT05833841
Brief Title
Swallowing Function in Patients With Head and Neck Cancers
Official Title
Assessment of Swallowing Function in Patients With Head and Neck Cancer Using Surface Electromyography and Video Fluoroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banaras Hindu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer, Oral Cancer
Keywords
Swallowing, Aspiration, Surgery, treatment, Dysphagia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of swallowing function
Arm Type
Experimental
Arm Description
Measurement of swallowing function using Surface Electromyography and video flouroscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
Surface Electromyography and Video fluoroscopy
Intervention Description
Surface EMG of three muscle groups (masseter, submental, and infrahyoid) and video fluoroscopy with Omnipaque
Primary Outcome Measure Information:
Title
Swallowing dysfunction assessed by fluoroscopy and EMG
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Pandey
Organizational Affiliation
Banaras Hindu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banaras Hindu University
City
Varanasi
State/Province
UP
ZIP/Postal Code
221005
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7805423
Citation
Kronenberger MB, Meyers AD. Dysphagia following head and neck cancer surgery. Dysphagia. 1994 Fall;9(4):236-44. doi: 10.1007/BF00301917.
Results Reference
background
PubMed Identifier
17078052
Citation
Dirix P, Nuyts S, Van den Bogaert W. Radiation-induced xerostomia in patients with head and neck cancer: a literature review. Cancer. 2006 Dec 1;107(11):2525-34. doi: 10.1002/cncr.22302.
Results Reference
background
PubMed Identifier
16302193
Citation
Logemann JA, Rademaker AW, Pauloski BR, Lazarus CL, Mittal BB, Brockstein B, MacCracken E, Haraf DJ, Vokes EE, Newman LA, Liu D. Site of disease and treatment protocol as correlates of swallowing function in patients with head and neck cancer treated with chemoradiation. Head Neck. 2006 Jan;28(1):64-73. doi: 10.1002/hed.20299.
Results Reference
background
PubMed Identifier
12953309
Citation
Al-Othman MO, Amdur RJ, Morris CG, Hinerman RW, Mendenhall WM. Does feeding tube placement predict for long-term swallowing disability after radiotherapy for head and neck cancer? Head Neck. 2003 Sep;25(9):741-7. doi: 10.1002/hed.10279.
Results Reference
background
PubMed Identifier
12874074
Citation
Carrara-de Angelis E, Feher O, Barros AP, Nishimoto IN, Kowalski LP. Voice and swallowing in patients enrolled in a larynx preservation trial. Arch Otolaryngol Head Neck Surg. 2003 Jul;129(7):733-8. doi: 10.1001/archotol.129.7.733.
Results Reference
background
PubMed Identifier
12792331
Citation
Kimata Y, Sakuraba M, Hishinuma S, Ebihara S, Hayashi R, Asakage T, Nakatsuka T, Harii K. Analysis of the relations between the shape of the reconstructed tongue and postoperative functions after subtotal or total glossectomy. Laryngoscope. 2003 May;113(5):905-9. doi: 10.1097/00005537-200305000-00024.
Results Reference
background
Learn more about this trial
Swallowing Function in Patients With Head and Neck Cancers
We'll reach out to this number within 24 hrs