Functional Results of Soft Palate Free Flap Reconstruction (RECaVoLL)
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|ClinicalTrials.gov Identifier: NCT03890783|
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : October 14, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|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|
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 :
Other: Evaluation of swallowing quality
Evaluation of swallowing quality by:
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
- 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.
- 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.
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
|Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon|
|Lyon, France, 69004|