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NCT Number: NCT03890783

Functional Results of Soft Palate Free Flap Reconstruction

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.

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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Palate Free Flap Reconstruction Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with oropharyngeal tumor who had surgical management with removal of all or part of the soft palate and free flap reconstruction, and at least 12 month after the end of external radiotherapy treatment
  • Patients over 18 years old

Exclusion criteria

  • Patients protected by law (guardianship, curatorship and under judicial protection)
  • Patients who expressed their opposition to participate to the study
  • Patients who do not speak French (incompatible with reading, understanding and filling out the questionnaires)
  • Patients participating in interventional research (excluding physiological studies and interventional research with minimal risks and constraints that do not interfere with the primary endpoint analysis)

Treatment and study plan

Evaluation of phonation quality

Other

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

Evaluation of swallowing quality

Other

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

global quality of life questionnaire

Other

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

Primary outcomes

  1. Evaluation of phonation quality at least 12 months after the end of external radiotherapy.

    Time frame: 12 months

    Self-evaluation by completion of the Voice Handicap Index questionnaire, in its 30 items version.

    For self evaluation of phonation using the Voice Handicap Index 30 (VHI 30) questionnaire:

    The VHI is rated on 120 points. For each question a score from 0 to 4 is assigned (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Its three sub-scales allow to establish an emotional score E out of 40, a physical score P out of 40 and a Functional score F out of 40.

    The total score can therefore be between 0 and 120 points. The interpretation of this test is done by comparing the sub-scores and the total score obtained with the averages values of these sub-scores and total score.

Secondary outcomes

  1. Hetero evaluation of phonation quality at least 12 months after the end of external radiotherapy

    Time frame: 12 months

    Hetero-evaluation performed by 3 practitioners, using the Grade Roughness Breathiness Asthenia Strain (GRBAS) score, after the patient has read and recorded two texts.

    GRBAS means: G for Grade (degree of hoarseness of the voice), R for Roughness (impression of irregularity of the vibration of the vocal folds), B for Breathiness (degree to which air escaping from between the vocal folds can be heard by the examiner), A for Asthenia (degree of weakness heard in the voice), S for Strain ( extent to which strain or hyperfunctional use of phonation is heard), I for Instability (changes in voice quality over time). Each of the five parameters is rated from 0 to 3 points (0 = Normal, 1 = slightly altered, 2 = moderately impaired, 3 = severely impaired), resulting in an overall score ranging from 0 to 15. A score at 0 reflects a phonation considered normal, a score between 1 and 5 a slightly altered phonation, between 5 and 10 moderately altered and between 10 and 15 severely impaired.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction

Acronym: RECaVoLL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2019
Registry last updated
Oct 14, 2020

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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