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CTRI Number  CTRI/2024/12/077995 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Structured swallowing exercises]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of post operative oral exercises on swallowing function in head and neck cancer patients  
Scientific Title of Study   Effect of Post-Operative Structured Oral Exercise therapy on swallowing function in oral cavity cancer patients: a Randomized Controlled Trial(POSE-SWALLOW) 
Trial Acronym  POSE-SWALLOW 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Pundir 
Designation  Senior Resident 
Affiliation  AIIMS Jodhpur 
Address  OPD room -509 ,5th floor ,A block ,Department of Surgical Oncology AIIMS Jodhpur ,Basni (Phase II),Industrial area

Jodhpur
RAJASTHAN
342005
India 
Phone  08755070407  
Fax    
Email  kirtipundir624@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nivedita Sharma 
Designation  Associate Professor,Department of Surgical oncology 
Affiliation  AIIMS Jodhpur 
Address  Room No. 3132 ,Medical college building ,Department of Surgical Oncology ,AIIMS Jodhpur ,Basni (Phase II),Industrial area
OPD room -509 ,5th floor ,A block ,Department of surgical oncology AIIMS Jodhpur ,Basni phase 2
Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nivedita Sharma 
Designation  Associate Professor,Department of Surgical oncology 
Affiliation  AIIMS Jodhpur 
Address  Room No. 3132 ,Medical college building ,Department of Surgical Oncology ,AIIMS Jodhpur ,Basni (Phase II),Industrial area
OPD room -509 ,5th floor ,A block ,Department of surgical oncology AIIMS Jodhpur ,Basni phase 2
Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences(AIIMS) ,Jodhpur ,Basni (Phase-II),Industrial area,Jodhpur, Rajasthan ,India -342005 
 
Primary Sponsor  
Name  Dr Kirti Pundir 
Address  OPD Room No 509,5th floor ,A block ,Department of surgical oncology,AIIMS Jodhpur ,Basni phase 2,Industrial area 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirti Pundir   All India Institute of Medical Sciences,Jodhpur  OPD Room No 509,5th floor ,A block ,Department of surgical oncology,AIIMS Jodhpur ,Basni phase (II),Industrial area, 342005
Jodhpur
RAJASTHAN 		 8755070407

kirtipundir624@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Clinical trial ),All India Institute of Medical Sciences (AIIMS)-Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  POSE Group(Structured oral exercises + standard care)  Self-administered swallowing exercises will be prescribed based on individual assessments and will have to be performed with up to 10 repetitions each, three times daily for 12 weeks. 
Comparator Agent  Standard Care group  Control group will receive instructions regarding standard care, including proper swallowing positions and proper food textures. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. All histopathologically proven operable SCC of oral cavity with stage (cT1-4b N1-3 M0) undergoing resection of primary tumor +/-reconstructive procedures with curative intent.
2. Patients who can tolerate atleast a thin liquid diet by postoperative day 10 of surgery.
3. ECOG PS 1-2
 
 
ExclusionCriteria 
Details  1. Recurrent oral cavity cancers.
2. Previous history of pharyngeal or esophageal malignancy.
3. Existing difficulty in swallowing due to causes other than current malignancy eg.hemiparesis, neuromuscular disorder etc.
4. Not giving informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard care (SC) at 4-6 weeks and 4-6 months post-surgery  4-6 weeks and 4-6 months post-surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the effect of POSE on other swallowing outcomes like Eating Assessment tool (EAT-10), tube dependency, mouth opening, gargle, whistle, pain at 4-6 weeks and 4-6 months post-surgery.
2. To assess the relationship between patient-reported symptoms of oropharyngeal dysphagia (OD) using EAT-10 and objective assessment of swallowing function like aspiration-penetration score and pharyngeal residue score using FEES.
3. To study the effect of POSE on speech as assessed by Continuous speech assessment in terms of speech intelligibility and didokokinesis.
4. To study the impact of POSE on health-related Quality of Life (HR-QOL) as measured by FACT-G and FACT-HN measured at 4-6 weeks and 4-6 month post-operatively.

 		 4-6 weeks and 4-6 months post-operatively. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kirtipundir624@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

This study aims to study the effect of postoperative oral exercises on swallowing function in terms of dysphagia, aspiration and oropharyngeal residues.The primary objective of the study remains to assess the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard  care (SC) at 4-6 weeks  and 4-6 months post-surgery. Secondary objectives include assessment of effect of POSE on functional outcomes and quality of life. All patients aged  18-75 years with ECOG PS 1-2and  histopathologically proven operable squamous cell carcinoma of oral cavity patients with stage (cT1-4b N1-3 M0) undergoing resection of primary tumor with or without reconstructive procedures with curative intent and patients who can tolerate atleast a thin liquid diet by postoperative day 10 of surgery will be included in the study whereas patients with recurrent oral cavity cancers,previous history of pharyngeal or esophageal malignancy or existing difficulty in swallowing due to causes other than current malignancy eg.hemiparesis, neuromuscular disorder etc. and patients not giving informed consentwill be excluded from the study. Post-operative Structured Oral Exercise Therapy (POSE) is expected to improve swallowing function in oral cavity cancer patients compared to patients who receive standard  care (SC) in post-operative period.


 
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