Swallowing Function in Patients With Head and Neck Cancers

NCT05833841 | Completed

• 1 other identifier: HNQOL1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Neck Cancer; Oral Cancer

Keywords

Swallowing; Aspiration; Surgery; treatment; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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

  6-8 weeks after surgery

Study Arms (1)

Evaluation of swallowing function

EXPERIMENTAL

Measurement of swallowing function using Surface Electromyography and video flouroscopy

Diagnostic Test: Surface Electromyography and Video fluoroscopy

Interventions

Surface Electromyography and Video fluoroscopy DIAGNOSTIC_TEST

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

Evaluation of swallowing function

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (6)

• Kronenberger MB, Meyers AD. Dysphagia following head and neck cancer surgery. Dysphagia. 1994 Fall;9(4):236-44. doi: 10.1007/BF00301917.

  PMID: 7805423 BACKGROUND

• 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.

  PMID: 17078052 BACKGROUND

• 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.

  PMID: 16302193 BACKGROUND

• 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.

  PMID: 12953309 BACKGROUND

• 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.

  PMID: 12874074 BACKGROUND

• 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.

  PMID: 12792331 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Deglutition Disorders

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Manoj Pandey

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)