Head Neck CancerNCT05833841
Swallowing Function in Patients With Head and Neck Cancers
A study testing Surface Electromyography and Video fluoroscopy in people with Head Neck Cancer and Oral Cancer, run by Banaras Hindu University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head Neck Cancer, Oral Cancer
- What is being tested?
- Surface Electromyography and Video fluoroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with neurological disease
- Pregnant and lactating women
- H/O any prior treatment such as Surgery, Chemotherapy, Radiotherapy Surgery for recurrent disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Swallowing Function in Patients With Head and Neck Cancer Using Surface Electromyography and Video Fluoroscopy
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.
Read the 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.
- Conditions
- Head Neck Cancer, Oral Cancer
- Being tested
- Surface Electromyography and Video fluoroscopy
- Keywords
- Swallowing, Aspiration, Surgery, treatment, Dysphagia
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electromyography and Video fluoroscopyDiagnostic test
Surface EMG of three muscle groups (masseter, submental, and infrahyoid) and video fluoroscopy with Omnipaque
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of swallowing function | Experimental | Measurement of swallowing function using Surface Electromyography and video flouroscopy Receives: Diagnostic Test: Surface Electromyography and Video fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 May 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Head Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Pandey, Banaras Hindu University
- Investigators
- Manoj Pandey, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833841
- Sponsor's protocol ID
- HNQOL1
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kronenberger MB, Meyers AD. Dysphagia following head and neck cancer surgery. Dysphagia. 1994 Fall;9(4):236-44. doi: 10.1007/BF00301917.
PubMed 7805423Dirix 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.
PubMed 17078052Logemann 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.
PubMed 16302193Al-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.
PubMed 12953309Carrara-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.
PubMed 12874074Kimata 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.
PubMed 12792331
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Swallowing Function in Patients With Head and Neck Cancer Using Surface Electromyography and Video Fluoroscopy
- ClinicalTrials.gov ID
- NCT05833841
- Acronym / sponsor ID
- HNQOL1
- Conditions
- Head Neck Cancer, Oral Cancer
- Keywords
- Swallowing, Aspiration, Surgery, treatment, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of swallowing function | Experimental | Diagnostic Test: Surface Electromyography and Video fluoroscopyMeasurement of swallowing function using Surface Electromyography and video flouroscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with neurological disease
- Pregnant and lactating women
- H/O any prior treatment such as Surgery, Chemotherapy, Radiotherapy Surgery for recurrent disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Electromyography and Video fluoroscopySurface EMG of three muscle groups (masseter, submental, and infrahyoid) and video fluoroscopy with Omnipaque | Diagnostic test | Evaluation of swallowing function |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 7805423Kronenberger MB, Meyers AD. Dysphagia following head and neck cancer surgery. Dysphagia. 1994 Fall;9(4):236-44. doi: 10.1007/BF00301917.
- Background: PubMed 17078052Dirix 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.
- Background: PubMed 16302193Logemann 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.
- Background: PubMed 12953309Al-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.
- Background: PubMed 12874074Carrara-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.
- Background: PubMed 12792331Kimata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Pandey principal investigator
Banaras Hindu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Electromyography and Video fluoroscopy in people with Head Neck Cancer and Oral Cancer, run by Banaras Hindu University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing dysfunction assessed by fluoroscopy and EMG (time frame: 6-8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833841, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.