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OpenTrials
Completed

NCT Number: NCT02156518

The Efficacy of Vocal Function Exercises for Laryngeal Cancers

The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hearing level and cognitive ability to follow test directions
  • Laryngeal cancer
  • Radiation Therapy completed >= 6 months
  • Deemed disease free by the treating physician
  • Subjects have to be willing to attend weekly voice therapy sessions

Exclusion criteria

  • Adjuvant treatment: laser or any surgical intervention
  • Neurological or cognitive impairment
  • Hearing levels that interfere with following test instruction
  • Vocal fold paralysis

Treatment and study plan

Vocal Function Exercises

Procedure

Vocal Function Exercises

Vocal Hygiene

Procedure

Vocal Hygiene

Primary outcomes

  1. Voice production

    Time frame: 6 weeks

    Voice Handicap Index, a validated self- assessment tool was used as the primary outcome measure. A score of 0 indicates no handicap, and a score of 120 indicates complete impairment. Data will be presented as pre and post treatment score (pre and post 6 weeks of therapy).

Sponsors and collaborators

Lead sponsor

Vrushali Angadi

Other

Registry information

Official study title

Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2014
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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