NCT05056064

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

January 25, 2024

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

September 5, 2021

Last Update Submit

January 24, 2024

Conditions

Oral Cavity Cancer

Keywords

Dysphagiaoral canceroral exercise

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (2)

CA oral cavity

EXPERIMENTAL

Standard Treatment+Oral exercise

Other: Oral exercise

control

NO INTERVENTION

Standard treatment

Interventions

Oral exerciseOTHER

exercise remain tongue

CA oral cavity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with CA tongue and tumor size 2 cm

You may not qualify if:

  • previous treatment
  • history of head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Mouth NeoplasmsDeglutition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2021

First Posted

September 24, 2021

Study Start

January 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

January 25, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)