Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Results of Soft Palate Free Flap Reconstruction (RECaVoLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890783
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
Oropharyngeal Cancer Palate Free Flap Reconstruction Other: Evaluation of phonation quality Other: Evaluation of swallowing quality Other: global quality of life questionnaire

Layout table for study information
Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : March 11, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients after surgery of oropharyngeal cancers
Patients after surgery of oropharyngeal cancers with soft palate with free flap reconstruction and adjuvant radiotherapy
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years of age, with oropharyngeal tumor requiring surgical management with excision of part or all of the soft palate, with free flap reconstruction
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890783


Locations
Layout table for location information
France
Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03890783    
Other Study ID Numbers: 69HCL18_0826
2018-A03408-47 ( Other Identifier: ID-RCB )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases