Clinical trial NCT03890783: Functional Results of Soft Palate Free Flap Reconstruction
Official title: Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Cancer
Palate Free Flap Reconstruction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: Evaluation of phonation quality at least 12 months after the end of external radiotherapy.
timeFrame: 12 months
Secondary outcomes:
measure: Hetero evaluation of phonation quality at least 12 months after the end of external radiotherapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon
Study officials:
References: