Cancer of the Head and Neck Clinical Trial
Official title:
The Effects of Expiratory Muscle Strength Training (EMST) on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
Radiation therapy for head and neck cancer (HNC) is associated with the development of
swallowing difficulties, or dysphagia. Dysphagia has profound negative effects on the health,
nutritional status, and quality of life of HNC survivors. It also puts them at risk of
developing life-threatening aspiration pneumonia. Radiation-associated dysphagia can be
intractable and not responsive to conventional dysphagia therapy. HNC survivors with chronic
severe dysphagia may be dependent on long-term tube feeding.
Expiratory Muscle Strength Training (EMST) is a low-cost, device-driven therapy. It has been
studied as an approach to simultaneously improve cough and swallowing functions. During EMST,
patients forcefully expire into a one-way spring-loaded valve to strengthen expiratory and
submental musculature. The EMST-150 device is available for clinical use in Singapore. In
other research studies, it has been shown to improve cough and swallowing in several
populations of people with chronic dysphagia, most recently in people with chronic
radiation-associated dysphagia.
The investigators propose to study the effect of EMST using the EMST-150 device on cough,
airway protection, and swallowing functions of HNC survivors with radiation-associated
dysphagia.
The investigators will recruit 40 participants to undergo an 8-week EMST programme, with
weekly follow-up to calibrate their EMST device. It is hypothesised that EMST will improve
participants' respiratory and swallowing functions. Respiratory function improvement will be
shown by increased maximum expiratory pressure and improved cough airflow measures.
Swallowing function improvement will be evidenced by reduced aspiration or improved ability
to clear aspirated material during videofluoroscopic swallow studies. The investigators also
hypothesize carryover effects on other aspects of swallowing, such as improved hyoid and
laryngeal excursions, and improved laryngeal vestibule closure.
With the results of this study, the investigators aim to develop better evidence-based
rehabilitation programmes for HNC survivors, and those living with chronic dysphagia.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 95 Years |
Eligibility |
Inclusion criteria - Chronic dysphagia involving the pharyngeal phase of swallowing for at least 6 months - Undergone radiation therapy for head and neck cancer - Penetration and/or aspiration seen on previous clinical videofluoroscopy swallow study (Penetration-Aspiration Scale score of 2 to 8) - Failure to respond to traditional dysphagia therapy, as indicated by no improvement or only an improvement of 1 point on the Functional Oral Intake Scale, over a period of at least 4 sessions of conventional dysphagia therapy. Exclusion criteria - Current pneumothorax - Severe trismus impeding insertion of rubber mouthpiece into the mouth (as part of treatment protocol) Patients who have "perforated tympanic membrane", "history of spontaneous pneumothorax" and "history of collapsed lung", will be considered on a case-by-case basis, depending on the stability of their condition. Permission from their primary team doctors, or ENT for tympanic membrane issues, will be sought prior to enrolment into the study. These participants will only be deemed suitable for the study if their primary team doctors, ENT or respiratory doctors agree that they are stable or fully recovered, and that doing EMST will not worsen these conditions. For these patient groups, permission from the patients' primary team doctors, ENT or Respiratory Doctors will be obtained via email. Participants will not be enrolled if there is no written consent indicating approval for subject to be enrolled. |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum expiratory pressure | cm H2O | up to 8-week intervention | |
Primary | Change in Penetration Aspiration Scale score | An 8-point rating scale of the severity of penetration and aspiration events | At baseline and end of 8-week intervention | |
Secondary | Functional Oral Intake Scale | A 7-point scale looking at the normalcy of diet consistencies taken by the patient. The lowest score is 1 (No oral intake) and the maximum score is 7 (total oral intake with no restrictions). | At baseline and end of 8-week intervention | |
Secondary | Performance Status Scale-Head and Neck | An oral intake scale looking at the normalcy of diet consistencies taken by the patient. The scale ranges from 0 (tube-feeding) to 100 (full diet with no restrictions), in increments of 10. | At baseline and end of 8-week intervention | |
Secondary | MD Anderson Dysphagia Inventory | Self-reported swallowing-related quality of life | At baseline and end of 8-week intervention | |
Secondary | Modified Barium Swallow Impairment Profile | Seventeen components of swallowing are visually rated on video recordings of the modified barium swallow procedure. | At baseline and end of 8-week intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04444869 -
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
|
Phase 2 | |
Terminated |
NCT01370876 -
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
Terminated |
NCT03297957 -
Fluorescence Imaging in Head and Neck Cancer
|
N/A | |
Completed |
NCT00716157 -
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
|
N/A | |
Recruiting |
NCT04880148 -
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
|
N/A | |
Completed |
NCT01017224 -
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
|
N/A | |
Completed |
NCT00798655 -
Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00496652 -
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
|
Phase 3 | |
Completed |
NCT00147472 -
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
|
Phase 3 | |
Completed |
NCT02880072 -
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
|
Phase 4 | |
Completed |
NCT01917942 -
Radiotherapy With Humidification in Head And Neck Cancer
|
Phase 3 | |
Recruiting |
NCT04865731 -
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT02442336 -
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
|
N/A | |
Completed |
NCT03102229 -
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
|
N/A | |
Completed |
NCT00474825 -
Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 | |
Recruiting |
NCT00180921 -
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
|
Phase 2 | |
Completed |
NCT01283334 -
A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT02557048 -
Head and Neck Cancer in Children: A Retrospective Study
|
||
Completed |
NCT02073032 -
Incidence and Risk Factors of Refeeding Syndrome
|
N/A | |
Active, not recruiting |
NCT02270814 -
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma
|
Phase 2 |