Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction
Sponsor
Rajavithi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05056064
Collaborator
(none)
90
1
2
16.9
5.3
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction: A Randomized Controlled Trial
Actual Study Start Date
:
Jan 1, 2021
Anticipated Primary Completion Date
:
May 31, 2022
Anticipated Study Completion Date
:
May 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CA oral cavity Standard Treatment+Oral exercise |
Other: Oral exercise
exercise remain tongue
|
| No Intervention: control Standard treatment |
Outcome Measures
Primary Outcome Measures
- Efficacy swallowing function [1 year]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patient with CA tongue and tumor size 2 cm
Exclusion Criteria:
-
previous treatment
-
history of head and neck cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rajavithi Hospital | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Rajavithi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT05056064
Other Study ID Numbers:
- 63222
First Posted:
Sep 24, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rajavithi Hospital
Additional relevant MeSH terms: