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CTRI Number  CTRI/2022/05/042391 [Registered on: 05/05/2022] Trial Registered Prospectively
Last Modified On: 27/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Speech therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of speech and swallow therapy on quality of life and speech intelligibility in patients with squamous cell carcinoma of tongue 
Scientific Title of Study   Effect of speech and swallow therapy on quality of life and speech intelligibility in patients with squamous cell carcinoma of tongue – A randomized control study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swathi Chenniappan 
Designation  Junior Resident (ENT) 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of ENT and Head and Neck Surgery, All India Institute of Medical Sciences, Sijua, Patrapada, PO Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  7708717772  
Fax    
Email  chenniappanswathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradipta Kumar Parida 
Designation  Additional Professor and HOD, Department of ENT and Head and Neck Surgery 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Third Floor, Academic Block, All India Institute of Medical Sciences, Sijua, Patrapada, PO Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9438884165  
Fax    
Email  ent_pradipta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pradipta Kumar Parida 
Designation  Additional Professor and HOD, Department of ENT and Head and Neck Surgery 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Third Floor, Academic Block, All India Institute of Medical Sciences, Sijua, Patrapada, PO Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9438884165  
Fax    
Email  ent_pradipta@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  All India Institute of Medical Sciences, Sijua, Patrapada, PO Dumuduma, Bhubaneswar, Odisha 
Type of Sponsor  Government medical college 
 
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 Swathi Chenniappan  AIIMS Bhubaneswar  All India Institute of Medical Sciences, Sijua, Patrapada, PO Dumuduma, Bhubaneswar
Khordha
ORISSA 		 7708717772

chenniappanswathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Post glossectomy patients not undergoing speech and swallow therapy  Post surgical speech assessment will be done at 15 days, 1 month, 3 months, 6 months postoperatively  
Intervention  Post glossectomy patients undergoing speech and swallow therapy  Speech intelligibility and articulatory skills for individual phonemes, words, short sentences and swallowing will be assessed. Based on these, patients will be given a set of oral motor exercises. Patients will also be advised to take up speech therapy sessions for 30 to 45 minutes, twice a week after post-operative day 7. Same exercises are to be continued at home on a regular basis. Improvements in articulation and swallowing will be assessed after two weeks, one month, three months and six months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with biopsy showing squamous cell carcinoma of tongue belonging to cT1 – 4a, N0 – 3, M0 receiving glossectomy as primary treatment, with or without flap reconstruction, belonging to both genders and age groups between 18 and 70 yrs will be included. 
 
ExclusionCriteria 
Details  1.Patients with advanced lesions cT4a with total tongue involvement
2.Recurrent disease
3.Prior history of surgery / chemoradiotherapy
4.Patients not willing for surgery
5.Not fit for surgery
6.Patients with distant metastasis. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of speech and swallow therapy on quality of life and speech intelligibility in patients undergoing wide local excision for squamous cell carcinoma of tongue with or without flap reconstruction.  15 days, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   06/05/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Head and neck cancer is a major health problem in 

the Indian subcontinent. Cancer outcomes are usually measured in terms of disease free survival, overall survival rate and other similar variables. Studies have shown that it is also vital to include the impact of the cancer and its treatment on patient’s quality of life as they have a role in survival. The European Organisation for Research & Treatment of Cancer  questionnaire will serve as a tool to assess the multidimensional aspects of quality of life in these patients.

 Intelligibility and articulation play a major role in determining the quality of speech. Impairments in pronunciation and speech are common in people with oral cavity and oropharyngeal cancers before and after surgery. Speech and swallow therapy in the post-op period may help to improve the intelligibility and thereby achieve a better quality of life in these patients. But the role of speech therapy is debatable. Hence, the study is being carried out to assess the impact of speech and swallow therapy on the quality of life and voice.


 
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