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Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis

Primary Purpose

Esophageal Stenosis, Deglutition Disorders, Head and Neck Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endoscopic injection of Mitomycin C
Sponsored by
Fauze Maluf Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Stenosis focused on measuring Endoscopic injection of Mitomycin C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Câncer do Estado de São Paulo - ICESP

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endoscopic injection of Mitomycin C

Arm Description

Endoscopy injection of Mitomycin C will be perform to the treatment of pharyngoesophageal stenosis refractory to endoscopic treatment with dilatation in patients with head and neck cancer

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

number of sessions of endoscopic dilations
decrease in the number of sessions of endoscopic dilations

Full Information

First Posted
March 22, 2018
Last Updated
May 17, 2018
Sponsor
Fauze Maluf Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03540953
Brief Title
Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
adverse events was observed in all of them, with intense neck pain and ulcer evelopment
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
May 5, 2015 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fauze Maluf Filho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
Management of pharyngoesophageal stenosis (PES) after cancer treatment in patients with head and neck cancer (HNC) remains a challenge. The etiology of PES in this group of patients is probably multifactorial, being associated with surgical manipulation, ischemic effects of radiotherapy and even cancer recurrence. It is estimated that up to 50% of patients treated for advanced HNC will present some degree of dysphagia. PES is a frequent cause of post treatment dysphagia of HNC patients. Although the exact prevalence is unknown, several retrospective series estimate that upper cervical stricture is present in 1% to 23% of the cases. The initial approach to PES is endoscopic dilation with a reported success rate ranging from 76% to 96%. In patients with refractory strictures to dilation sessions, endoscopic corticosteroid injection, such as triamcinolone, is usually added to the dilation sessions, which may increase the success of the endoscopic treatment. A relatively small group of patients will be refractory to the association of dilation and corticosteroid injection treatment. Metal stents may be considered in this scenario, but in the case of pharyngoesophageal stenosis, this approach is limited by cervical pain and foreign body sensation. Surgical reconstruction for pharyngoesophageal stenosis refractory to endoscopic treatment is the last therapeutic option (2). Previous radiotherapy, eventual reconstruction with cutaneous flaps make a surgical manipulation of the cervical region a real challenge, with increased adverse event rate, including restenosis.(2) Because of such difficulties, this prospective study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection for the treatment of pharyngoesophageal stenoses in patients who were treated for head and neck cancer, refractory to endoscopic dilation treatment. There are descriptions of the use of Mitomycin C for scar prevention after ophthalmologic and otorhinolaryngological interventions (8). Its use in endoscopy has previously been described for the treatment of laryngeal and tracheal stenosis as well as refractory esophageal stenosis. Mitomycin C is a substance isolated from the bacterium Streptomyces caespitosus, which is used as a chemotherapeutic agent and has antiproliferative effects on fibroblasts, reducing fibroblast proliferation and collagen formation. Some studies demonstrated the ability to decrease fibroblast activity and consequent scar formation after the application of Mitomycin C on culture of fibroblasts in low concentrations (0.1 to 0.4 mg / ml) for 5 to 10 minutes, affecting their proliferation for over 3 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stenosis, Deglutition Disorders, Head and Neck Neoplasms, Esophageal Neoplasms
Keywords
Endoscopic injection of Mitomycin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic injection of Mitomycin C
Arm Type
Other
Arm Description
Endoscopy injection of Mitomycin C will be perform to the treatment of pharyngoesophageal stenosis refractory to endoscopic treatment with dilatation in patients with head and neck cancer
Intervention Type
Drug
Intervention Name(s)
Endoscopic injection of Mitomycin C
Intervention Description
administration included dilation of the stenotic segment with thermoplastic bougies, followed by the injection of 3mg of Mitomycin C, divided into 4 aliquots of 0.75mg, injected in the four quadrants, at the stenosis level.
Primary Outcome Measure Information:
Title
dysphagia
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
number of sessions of endoscopic dilations
Description
decrease in the number of sessions of endoscopic dilations
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis

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