Functional Results of Soft Palate Free Flap Reconstruction

NCT03890783 | Completed

• 2 other identifiers: 69HCL18_08262018-A03408-47
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancer; Palate Free Flap Reconstruction

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

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; Other: Evaluation of swallowing quality; Other: global quality of life questionnaire

Interventions

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

Patients after surgery of oropharyngeal cancers

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

Patients after surgery of oropharyngeal cancers

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

Patients after surgery of oropharyngeal cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: March 26, 2019
• Study Start: February 27, 2019
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)