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Functional Results of Soft Palate Free Flap Reconstruction

NCT03890783 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2020-10-14

No results posted yet for this study

Summary

The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation.

The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.

Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.

It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.

There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.

Conditions

  • Oropharyngeal Cancer
  • Palate Free Flap Reconstruction

Interventions

OTHER

Evaluation of phonation quality

Evaluation of phonation quality by : * Self-evaluation: completion of the Voice Handicap Index questionnaire, in its 30 items version * Hetero-evaluation: reading and recording of 2 texts, and notation by 3 practitioners using the grade, rough, breathy, asthenic, strained (GRBAS) scale, to evaluate the occurrence and the gravity of rhinolalia

OTHER

Evaluation of swallowing quality

Evaluation of swallowing quality by: * Self-evaluation: completion of the Deglutition Handicap Index questionnaire * Hetero-evaluation: nasofibroscopy to evaluate the occurrence of aspiration and nasal regurgitation

OTHER

global quality of life questionnaire

Completion of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ - C30) and the EORTC QLQ - H\&N35 questionnaires

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2020-03-11
Completion
2020-03-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890783 on ClinicalTrials.gov