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NCT03890783: RECaVoLL
Functional Results of Soft Palate Free Flap Reconstruction
trial testing Evaluation of phonation quality in Oropharyngeal Cancer in 29 participants. Completed in 11 March 2020.
11 March 2020
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 27 February 2019 |
| Primary completion | 11 March 2020 |
| Estimated completion | 11 March 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Evaluation of phonation quality
- Evaluation of swallowing quality
- global quality of life questionnaire
Conditions studied
- Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →
- Palate Free Flap Reconstruction — all drugs for Palate Free Flap Reconstruction →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Oropharyngeal Cancer or Palate Free Flap Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03890783
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Oropharyngeal Cancer
Currently open trials in the same condition.
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Other Hospices Civils de Lyon trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03890783 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 14 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03890783.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing