Head and Neck Neoplasms Clinical Trial
Official title:
Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis Refractory to Endoscopic Treatment With Dilatation in Patients With Head and Neck Cancer
Verified date | March 2018 |
Source | Instituto do Cancer do Estado de São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Management of pharyngoesophageal stenosis (PES) in patients after head and neck cancer (HNC)
treatment remains a challenge. There are some cases of strictures refractory to dilation
sessions. This study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection
for the treatment of refractory pharyngoesophageal stenosis.
Patients and methods: This is a prospective study in patients with dysphagia following head
and neck cancer treatment, without evidence suggestive of tumor recurrence, and refractory to
endoscopic treatment. Theses undergo endoscopic dilation of the stenotic segment with
thermoplastic bougies, followed by the injection of MMC.
Status | Terminated |
Enrollment | 12 |
Est. completion date | January 5, 2018 |
Est. primary completion date | May 5, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with dysphagia following head and neck cancer treatment - Patients without endoscopic or radiological evidence suggestive of tumor recurrence - Patients refractory to endoscopic treatment Exclusion Criteria: - Endoscopic or radiological signs suggestive of tumor recurrence |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto do Câncer do Estado de São Paulo - ICESP | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Fauze Maluf Filho |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | dysphagia | dysphagia score (0 = able to eat normal diet / no dysphagia;1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia) | 2 years | |
Secondary | number of sessions of endoscopic dilations | decrease in the number of sessions of endoscopic dilations | 2 years |
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