Oropharyngeal CancerNCT01767961
Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
A study testing diagnostic imaging, questionnaire administration and quality-of-life assessment in people with Oropharyngeal Cancer, run by Wake Forest University Health Sciences.
Trial summary
This pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. New diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who… Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- diagnostic imaging, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jan 2015
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have undergone TORS or CRT for oropharyngeal carcinoma 6-24 months prior at Wake Forest University Baptist Hospital (WFUBH)
- In CRT treated participants, CRT had to be delivered as a primary modality with curative intent
- In TORS treated participants, TORS had to be done as a primary modality with curative intent
- Written informed consent
- No evidence of recurrent disease or second primary tumors on physical examination
Who cannot join
- Previous head and neck surgery, radiation, or chemotherapy preceding TORS
- Previous head and neck surgery preceding CRT
- If CRT patient, candidacy for TORS is not met
- Known neurologic dysfunction affecting swallowing
- Evidence of recurrent or second primary cancers on examination
- Patient pregnancy (due to radiation exposure risk to unborn fetus)
- Inability to grant informed consent
About this study
Official title: A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
This pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. New diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who received treatment for oropharyngeal cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To compare aspiration in oropharyngeal carcinoma patients that underwent transoral robotic surgery (TORS) vs. chemoradiotherapy (CRT) via an objective instrument, the modified barium swallow (MBS).
SECONDARY OBJECTIVES:
- To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a subjective instrument, the M.D. Anderson Dysphagia Inventory (MDADI) using the total MDADI score.
II. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a second subjective instrument, the Eating Assessment Tool (EAT-10) using the total EAT-10 score.
III. To estimate the correlation between the maximum Penetration Aspiration Scale (PAS) score and MDADI total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
IV. To estimate the correlation between the maximum PAS score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
- To estimate the correlation between MDADI total score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
VI. To estimate cervical esophageal stricture diameters after TORS vs. CRT via an objective instrument, the MBS.
OUTLINE:
Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.
- Conditions
- Oropharyngeal Cancer
- Being tested
- diagnostic imaging, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic imagingProcedure or surgery
Undergo MBS
questionnaire administrationOther
Correlative studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (modified barium swallow) | Experimental | Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging. Receives: Procedure: diagnostic imaging; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
The maximum PAS score will be dichotomized into aspiration vs no aspiration. The highest (closest to 8 on the PAS scale) PAS score of the 10 swallows will be used for dichotomization. A PAS score of 6 or greater indicates aspiration, while a PAS score of 5 or less is indicative of no aspiration. McNemar's test for correlated proportions will be used to assess the difference between the two treatment groups.
Measured: Baseline
Secondary outcomes (3)
Swallowing function, assessed by the MDADI score
The total MDADI score will be analyzed using paired t-tests.
Measured: Baseline
Perceived subjective swallowing function, assessed using the EAT-10
The total EAT-10 score will be analyzed using paired t-tests.
Measured: Baseline
Cervical esophageal stricture measurements
A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Unable to secure funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joshua Waltonen, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767961
- Sponsor's protocol ID
- CCCWFU 97312
- Other IDs
- NCI-2012-02165, P30CA012197
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2013
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01767961
- Acronym / sponsor ID
- CCCWFU 97312
- Conditions
- Oropharyngeal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 2013 (estimated)
- 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.
This pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. New diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who received treatment for oropharyngeal cancer
Detailed description
PRIMARY OBJECTIVES:
- To compare aspiration in oropharyngeal carcinoma patients that underwent transoral robotic surgery (TORS) vs. chemoradiotherapy (CRT) via an objective instrument, the modified barium swallow (MBS).
SECONDARY OBJECTIVES:
- To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a subjective instrument, the M.D. Anderson Dysphagia Inventory (MDADI) using the total MDADI score.
II. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a second subjective instrument, the Eating Assessment Tool (EAT-10) using the total EAT-10 score.
III. To estimate the correlation between the maximum Penetration Aspiration Scale (PAS) score and MDADI total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
IV. To estimate the correlation between the maximum PAS score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
- To estimate the correlation between MDADI total score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.
VI. To estimate cervical esophageal stricture diameters after TORS vs. CRT via an objective instrument, the MBS.
OUTLINE:
Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (modified barium swallow) | Experimental | Procedure: diagnostic imaging, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have undergone TORS or CRT for oropharyngeal carcinoma 6-24 months prior at Wake Forest University Baptist Hospital (WFUBH)
- In CRT treated participants, CRT had to be delivered as a primary modality with curative intent
- In TORS treated participants, TORS had to be done as a primary modality with curative intent
- Written informed consent
- No evidence of recurrent disease or second primary tumors on physical examination
Key exclusion criteria (7 listed)
- Previous head and neck surgery, radiation, or chemotherapy preceding TORS
- Previous head and neck surgery preceding CRT
- If CRT patient, candidacy for TORS is not met
- Known neurologic dysfunction affecting swallowing
- Evidence of recurrent or second primary cancers on examination
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 |
|---|---|---|
| diagnostic imagingUndergo MBS | Procedure or surgery | Diagnostic (modified barium swallow) |
| questionnaire administrationCorrelative studies | Other | Diagnostic (modified barium swallow) |
| quality-of-life assessmentAlso: quality of life assessmentCorrelative studies | Procedure or surgery | Diagnostic (modified barium swallow) |
Primary outcome
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
Time frame: Baseline
The maximum PAS score will be dichotomized into aspiration vs no aspiration. The highest (closest to 8 on the PAS scale) PAS score of the 10 swallows will be used for dichotomization. A PAS score of 6 or greater indicates aspiration, while a PAS score of 5 or less is indicative of no aspiration. McNemar's test for correlated proportions will be used to assess the difference between the two treatment groups.
3 secondary outcomes
Swallowing function, assessed by the MDADI score
Time frame: Baseline
Perceived subjective swallowing function, assessed using the EAT-10
Time frame: Baseline
Cervical esophageal stricture measurements
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
Related trials for Oropharyngeal Cancer
Active, not recruitingPhase 3
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
Oropharynx Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Joshua Waltonen principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic imaging, questionnaire administration and quality-of-life assessment in people with Oropharyngeal Cancer, run by Wake Forest University Health Sciences.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Aug 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS (time frame: Baseline). 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 10 Aug 2017.