Esophageal StenosisNCT03540953
Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis
A study testing Endoscopic injection of Mitomycin C in people with Esophageal Stenosis and Deglutition Disorders, run by Fauze Maluf Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stenosis, Deglutition Disorders, Head and Neck Neoplasms
- What is being tested?
- Endoscopic injection of Mitomycin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2015to 5 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dysphagia following head and neck cancer treatment
- Patients without endoscopic or radiological evidence suggestive of tumor recurrence
- Patients refractory to endoscopic treatment
Who cannot join
- Endoscopic or radiological signs suggestive of tumor recurrence
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, 01246-000
About this study
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
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.
Read the 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.
- Being tested
- Endoscopic injection of Mitomycin C
- Keywords
- Endoscopic injection of Mitomycin C
- Medical subject headings
- Esophageal Stenosis, Deglutition Disorders, Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic injection of Mitomycin CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic injection of Mitomycin C | Other | 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 Receives: Drug: Endoscopic injection of Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (1)
number of sessions of endoscopic dilations
decrease in the number of sessions of endoscopic dilations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start5 Jan 2015
- Primary completion5 May 2015
- Study completion5 Jan 2018
Why it stopped: adverse events was observed in all of them, with intense neck pain and ulcer evelopment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fauze Maluf Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540953
- Sponsor's protocol ID
- NP549/14
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 30 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03540953
- Acronym / sponsor ID
- NP549/14
- Keywords
- Endoscopic injection of Mitomycin C
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: adverse events was observed in all of them, with intense neck pain and ulcer evelopment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fauze Maluf FilhoUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 5 May 2015 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic injection of Mitomycin C | Other | Drug: Endoscopic injection of Mitomycin CEndoscopy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with dysphagia following head and neck cancer treatment
- Patients without endoscopic or radiological evidence suggestive of tumor recurrence
- Patients refractory to endoscopic treatment
Key exclusion criteria (1 listed)
- Endoscopic or radiological signs suggestive of tumor recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic injection of Mitomycin Cadministration 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. | Drug | Endoscopic injection of Mitomycin C |
Primary outcome
dysphagia
Time frame: 2 years
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)
1 secondary outcome
number of sessions of endoscopic dilations
Time frame: 2 years
Results and safety
The study was stopped early (reason given: adverse events was observed in all of them, with intense neck pain and ulcer evelopment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic injection of Mitomycin C in people with Esophageal Stenosis and Deglutition Disorders, run by Fauze Maluf Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: adverse events was observed in all of them, with intense neck pain and ulcer evelopment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dysphagia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.