DysphagiaPhase 2NCT00094861
Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Palifermin, Radiotherapy and Paclitaxel in people with Dysphagia and Non-Small Cell Lung Cancer, run by Swedish Orphan Biovitrum.
Trial summary
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Non-Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- Palifermin, Radiotherapy and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 a histologically or cytologically proven diagnosis of NSCLC
- Unresectable (locally advanced) stage IIIa or IIIb disease
- Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus
- Life expectancy greater than or equal to 6 months
- Estimated weight loss less than or equal to 10% in the 3 months before study randomization
- Measurable disease
Show all 16Show fewer
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization
- Platelet count greater than or equal to 100 x 10^9/L
- Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)
- Serum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)
- Females of childbearing potential: negative serum or urine pregnancy test
- Patient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.
- Patients with reproductive capability must agree to practice adequate contraception methods.
Who cannot join
- Metastatic disease (M1)/stage 4 NSCLC
- Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized.
- Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy course
- Shielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding)
- Prior chemotherapy, radiotherapy, or surgery for NSCLC
- Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Patients with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before patient is randomized.
Show all 17Show fewer
- Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)
- History of pancreatitis
- Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment
- Previous treatment on this study or with a fibroblast growth factor
- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
- Pregnant or breastfeeding women
- Known sensitivity to E. coli derived products
- Compromised ability of the patient to give written informed consent and/or to comply with study procedures
- Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable
- Unwilling or unable to complete the patient reported outcome (PRO) questionnaires
- Psychological, social, familial, or geographical reasons that would prevent regular follow-up
About this study
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
During the acute dysphagia evaluation phase (the period lasting from the administration of the first dose of investigational product through Week 12 (or up to Week 16 if dysphagia is not resolved to CTCAE v3.0 grade ≤ 1 by Week 12) participants underwent acute dysphagia assessments twice weekly. All participants were followed for disease progression, second primary tumors, other malignancies, and overall survival until death or loss to follow-up during the long term follow-up (still ongoing).
- Conditions
- Dysphagia, Non-Small Cell Lung Cancer, Lung Cancer
- Being tested
- Palifermin, Placebo, Radiotherapy, Paclitaxel, Carboplatin
- Keywords
- dysphagia, palifermin, KGF, chemoradiotherapy, NSCLC, non-small cell lung cancer, lung cancer, supportive care, clinical trial, consolidation chemotherapy, radiotherapy
- Medical subject headings
- Deglutition Disorders, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliferminDrug
Also called Recombinant Human Keratinocyte Growth Factor, rHuKGF, Kepivance
PlaceboDrug
RadiotherapyRadiation
PaclitaxelDrug
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:
* standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
* paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
* carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).
Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0. Receives: Drug: Placebo; Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Carboplatin |
| Palifermin | Experimental | Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:
* standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
* paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
* carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).
Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0. Receives: Drug: Palifermin; Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Higher Dysphagia
Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation).
Measured: Start of treatment through Week 16
Secondary outcomes (7)
Duration of Grade 2 or Higher Dysphagia
Duration of grade 2 or higher dysphagia was calculated in days from the onset (first occurrence of grade ≥ 2) to the resolution (grade ≤ 1 after the last grade ≥ 2) of dysphagia.
Participants with no assessments were assumed as having grade ≥ 2 dysphagia and with a duration of the mean duration of all participants.
Measured: Start of treatment through Week 16
Maximal Dysphagia Grade
The mean maximal grade of dysphagia for each participant during the study. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation).
Measured: Start of treatment through Week 16
Number of Participants With Severe (Grade 3 or Higher) Dysphagia
Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation).
Measured: Start of treatment through Week 16
Number of Participants With Unplanned Breaks in Radiotherapy
The number of participants with unplanned breaks in radiotherapy of ≥ 5 days or who discontinued radiotherapy during Week 1 to Week 6.
Measured: Week 1 to Week 6
Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase
Maximal increase from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status. ECOG is a scale to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead.
Measured: Baseline through Week 12
Number of Participants Hospitalized
Measured: Baseline to Week 16
Maximal Body Weight Loss
Maximal weight loss observed from Baseline through to Week 12.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2004 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094861
- Sponsor's protocol ID
- 20030185
- Status last verified
- Feb 2017
- First submitted
- 27 Oct 2004
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00094861
- Acronym / sponsor ID
- 20030185
- Conditions
- Dysphagia, Non-Small Cell Lung Cancer, Lung Cancer
- Keywords
- dysphagia, palifermin, KGF, chemoradiotherapy, NSCLC, non-small cell lung cancer, lung cancer, supportive care, clinical trial, consolidation chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Oct 2004 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
Detailed description
During the acute dysphagia evaluation phase (the period lasting from the administration of the first dose of investigational product through Week 12 (or up to Week 16 if dysphagia is not resolved to CTCAE v3.0 grade ≤ 1 by Week 12) participants underwent acute dysphagia assessments twice weekly. All participants were followed for disease progression, second primary tumors, other malignancies, and overall survival until death or loss to follow-up during the long term follow-up (still ongoing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Radiation: Radiotherapy, Drug: Paclitaxel, Drug: CarboplatinParticipants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy was given as follows: * standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy * paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy) * carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy). Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0. |
| Palifermin | Experimental | Drug: Palifermin, Radiation: Radiotherapy, Drug: Paclitaxel, Drug: CarboplatinParticipants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows: * standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy * paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy) * carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy). Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with a histologically or cytologically proven diagnosis of NSCLC
- Unresectable (locally advanced) stage IIIa or IIIb disease
- Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus
- Life expectancy greater than or equal to 6 months
- Estimated weight loss less than or equal to 10% in the 3 months before study randomization
Key exclusion criteria (17 listed)
- Metastatic disease (M1)/stage 4 NSCLC
- Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized.
- Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy course
- Shielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding)
- Prior chemotherapy, radiotherapy, or surgery for NSCLC
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 |
|---|---|---|
| PaliferminAlso: Recombinant Human Keratinocyte Growth Factor, rHuKGF, Kepivance | Drug | Palifermin |
| Placebo | Drug | Placebo |
| Radiotherapy | Radiation | Palifermin, Placebo |
| Paclitaxel | Drug | Palifermin, Placebo |
| Carboplatin | Drug | Palifermin, Placebo |
Primary outcome
Number of Participants With Grade 2 or Higher Dysphagia
Time frame: Start of treatment through Week 16
Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following: Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation).
7 secondary outcomes
Duration of Grade 2 or Higher Dysphagia
Time frame: Start of treatment through Week 16
Maximal Dysphagia Grade
Time frame: Start of treatment through Week 16
Number of Participants With Severe (Grade 3 or Higher) Dysphagia
Time frame: Start of treatment through Week 16
Number of Participants With Unplanned Breaks in Radiotherapy
Time frame: Week 1 to Week 6
Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase
Time frame: Baseline through Week 12
Number of Participants Hospitalized
Time frame: Baseline to Week 16
Maximal Body Weight Loss
Time frame: Baseline through Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palifermin, Radiotherapy and Paclitaxel in people with Dysphagia and Non-Small Cell Lung Cancer, run by Swedish Orphan Biovitrum.
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 16 inclusion and 17 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Grade 2 or Higher Dysphagia (time frame: Start of treatment through Week 16). 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 14 Mar 2017.