| CTRI Number |
CTRI/2026/01/101318 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Assess the effect of Expiratory Muscle Strength Training (EMST) DEVICE on Swallow Function and Aspiration prevention in patients after Tongue Cancer Surgery. |
|
Scientific Title of Study
|
Effect of Expiratory Muscle Strength Training on Dysphagia and Aspiration Prevention in Post Glossectomy Patients A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Manish Verma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi South DELHI 110029 India |
| Phone |
9289449265 |
| Fax |
|
| Email |
mventhns@aiims.edu |
|
Details of Contact Person Scientific Query
|
| Name |
DR Rajeev Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi South DELHI 110029 India |
| Phone |
01126593386 |
| Fax |
|
| Email |
rajeev9843@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DR Manish Verma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi South DELHI 110029 India |
| Phone |
01126593386 |
| Fax |
|
| Email |
mventhns@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology and Head Neck Surgery, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Manish Verma |
AIIMS, New Delhi |
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
South DELHI |
9289449265
mventhns@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMST DEVICE |
EMST focuses on strengthening mechanisms of airway protection and defence. EMST has been shown to increase expiratory pressure generation by 30% to 150%, with an average of 50% in a 4-week period of time by improving closure for swallowing by exercise of swallowing-related muscles such as those in the submental suprahyoid region. |
| Comparator Agent |
Standard Postop Physiotherapy |
Standard Post operative physiotherapy exercises which include chin tuck, head turns, and supraglottic swallow will be advised to the individuals in the control group. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary respectable tumor of Tongue.
2. Histologically proven SCC of Tongue.
3. Patient undergoing Compartmental, Subtotal, Near Total Glossectomies.
|
|
| ExclusionCriteria |
| Details |
1. Chronic radiation exposed patients of Tongue carcinoma.
2. Recurrent/ Relapsed and metastatic patients/ Unresectable cases.
3. Neurological disorders affecting swallowing, Prior swallowing impaired or Severe dysphagia patients.
4. Severe Cardiopulmonary conditions impacting expiratory efforts.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in MEP (cm H20) from baseline to 4weeks |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to removal of Ryles Tube (days post-surgery)
2. Aspiration events in control vs treatment groups
3. QoL improvement (MDADI score) at 4 and 8 weeks .
4. Improvement in FEES-based Score at 4 and 8weeks.
|
2years |
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Global incidence trends in Head and Neck cancer worldwide. The overall incidence of HNC continues to rise, with a predict 30 percent increase annually by 2030. The majority of new cases of HNSCC annually are related to smoking and alcohol consumption with five year survival rate only approximately 50 percent . Surgery is an effective treatment for these patients. However dysphagia and aspiration occur frequently post operatively with Tongue cancer having majority of burden. The degree of dysphagia depends on the amount of normal tissue resected and they have a poor quality of life and develop anxiety and depression when they aspirate and become dependent on Tracheostomy Tube and Ryles tube. We routinely provide standard exercise therapy post operatively like chin tuck or head turns and supraglottic swallow. But despite notable refinements in swallow therapy over the last three decades attempts to reverse aspiration with swallowing therapy are often disappointing. Therefore new emerging devices like EMST means Expiratory muscle strength training device are inexpensive and provide device driven exercise therapy. During EMST our task is to strengthen recruited muscles over time. EMST acts on one of two mechanisms one by Strengthening subglottic expiratory pressure generating forces, translating to a stronger cough to clear aspirate from the lower airway or Improving airway closure for swallowing by exercise of swallowing related muscles such as those in the submental suprahyoid region. Rationale of EMST device in HNC patients In several populations to date EMST has been shown to increase expiratory pressure generation by 30 percent to 150percent with an average of 50 percent in a 4 weeks period of time. EMST is accordingly gaining popularity among various populations with swallowing disorders but to our knowledge the results of EMST have not evaluated in Tongue patients. Thus the purpose of this study will be to examine the therapeutic potential of EMST among Post Glossectomy associated aspiration and dysphagia. We hypothesize that expiratory force generating capacity indicated by Maximum expiratory pressures and swallowing safety by Penetration or Aspiration measured by Functional endoscopic evaluation of swallowing would improve after 4 weeks of EMST. |