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Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction

Primary Purpose

Oral Cavity Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Oral exercise
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cavity Cancer focused on measuring Dysphagia, oral cancer, oral exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with CA tongue and tumor size 2 cm

Exclusion Criteria:

  • previous treatment
  • history of head and neck cancer

Sites / Locations

  • Rajavithi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CA oral cavity

control

Arm Description

Standard Treatment+Oral exercise

Standard treatment

Outcomes

Primary Outcome Measures

Efficacy swallowing function
Efficacy of swallowing function evaluate by Penetration-Aspiration scale by Rosenbek, this questionnaire classify patient for 8 score, from no entry of material into the larynx or trachea to material enters the trachea with no attempt to clear

Secondary Outcome Measures

Full Information

First Posted
September 5, 2021
Last Updated
November 17, 2021
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05056064
Brief Title
Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction
Official Title
Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Cancer
Keywords
Dysphagia, oral cancer, oral exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CA oral cavity
Arm Type
Experimental
Arm Description
Standard Treatment+Oral exercise
Arm Title
control
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Other
Intervention Name(s)
Oral exercise
Intervention Description
exercise remain tongue
Primary Outcome Measure Information:
Title
Efficacy swallowing function
Description
Efficacy of swallowing function evaluate by Penetration-Aspiration scale by Rosenbek, this questionnaire classify patient for 8 score, from no entry of material into the larynx or trachea to material enters the trachea with no attempt to clear
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with CA tongue and tumor size 2 cm Exclusion Criteria: previous treatment history of head and neck cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasipim Boonpeng, MD
Phone
0863937223
Email
praew.7676@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tatsanachat Jittreet, MD
Phone
089 922 9272
Email
Trapezius88@hotmail.com
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasipim Boonpeng, MD
Phone
0819066659
Email
praew.7676@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction

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