Head and Neck CancerQUASARNCT04359199
QUantitative Assessment of Swallowing After Radiation (QUASAR)
An observational study of Head and Neck Cancer and Dysphagia, run by Loren Mell, MD at 2 sites in United States.
Trial summary
To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia
- What is being tested?
- Radiation Therapy, Cetuximab and Chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2020to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients with head and neck carcinoma treated with definitive radiation therapy and systemic therapy (chemotherapy or immunotherapy) in the University of California San Diego Healthcare System will be eligible.
Who may be able to join
- Biopsy-proven, un-resected invasive carcinoma of the head and neck.
- Treated with definitive RT and concurrent systemic therapy or treated within the past 4-24 months
- Concurrent systemic therapy with Cisplatin, Cetuximab or immunotherapy.
- Age ≥ 18
- Able to understand and willing to sign a written informed consent.
Who cannot join
- Prior radiotherapy that would result in overlap of planned radiation therapy fields.
- Prior systemic chemotherapy, unless as part of the coordinated plan of care for the treatment of the carcinoma (e.g., induction/neoadjuvant chemotherapy is allowed)
- Planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Khushbu Singh, MBBS, CCRP, 858-246-2604
Loren Mell, MD
- Recruiting
UCSD Moores Cancer Center
La Jolla, California, 92093
Gerald Henderson, BA, 858-822-5223, gehenderson@ucsd.edu
About this study
Official title: QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients
To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab).
Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).
Read the detailed description
The QUASAR study will use a prospective, observational, cross sectional design (See Schema). HNC patients treated with definitive RT and immunotherapy or chemotherapy (cetuximab or cisplatin) will undergo VFSS at 4-6 and 12-24 months post-treatment. Patients enrolled prior to 6 months after finishing therapy will undergo a swallow study during the 4-6 month period AND the 12-24 month period. Patients enrolled after 6 months after finishing therapy will undergo a single swallow study in the 12-24 month period. The primary endpoint of PCR at 12-24 months will be compared between patients treated with immunotherapy versus chemotherapy.
All patients with HNC treated with definitive RT and systemic therapy at our institution will be eligible. In particular, we will recruit patients for this study from participants in two ongoing trials investigating the use of concurrent immunotherapy. The KEYCHAIN trial (ClinicalTrials.gov Identifier: NCT03383094) randomizes patients with locally advanced p16+ HNC undergoing definitive RT to concurrent q3 week cisplatin versus concurrent and adjuvant pembrolizumab. NRG-HN004 (ClinicalTrials.gov Identifier: NCT03258554) is a cooperative group trial that compares HNC patients that are not eligible for cisplatin undergoing definitive radiation therapy to concurrent cetuximab versus durvalumab.
- Conditions
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma
- Being tested
- Radiation Therapy, Cetuximab, Chemotherapy, Immunotherapy
- Keywords
- head and neck cancer, oropharyngeal dysphagia, radiation therapy, immunotherapy, videofluoroscopic swallow study, modified barium swallow study, oropharynx cancer, oropharynx squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called radiotherapy, RT
Routine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer
CetuximabDrug
Also called Erbitux
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of head and neck cancer
ChemotherapyDrug
Also called Cisplatin
Cisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer
ImmunotherapyDrug
Also called pembrolizumab, Keytruda, nivolumab, Opdivo
Keytruda or Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface.
Opdivo or Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody.
Imfinzi or Durvalumab is an anti-cancer ("antineoplastic") drug. This medication is classified as an Anti-PD-L1 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy with chemotherapy | Patients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab) Receives: Radiation: Radiation Therapy; Drug: Cetuximab; Drug: Chemotherapy | |
| Radiotherapy with immunotherapy | Patients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab) Receives: Radiation: Radiation Therapy; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR
will use a two-sample t-test at 0.05 level to compare Pharyngeal Constriction Ratio (PCR) between groups
Measured: 12-24 months
Secondary outcomes (3)
Quantitative swallowing function at 4-6 months and 12-24 months by PCR, TPT, PRR and PPWT
To compare swallowing function between systemic therapies with additional quantitative metrics of swallowing dysfunction from the VFSS including TPT, PRR and PPWT.
The presence of aspiration or strictures on VFSS will be compared as binary variables between groups using Pearson's Chi squared test.
Measured: 4-6 months and 12-24 months
Correlation between quantitative swallowing function and patient reported symptoms using the EAT-10 tool
To compare patient reported assessments of swallowing function with the EAT-10 tool between systemic therapies.
To test if there is correlation between the quantitative VFSS metrics and patient reported outcomes on the EAT-10 index, we will calculate Pearson's correlation coefficient and plot the results on a correlation matrix. The Holm step down procedure will be used to adjust for multiple testing to control the family-wise error rate at 0.05 level.
Measured: 12-24 months
Correlation between radiation dose and location of swallowing function and quantitative swallowing function
The purpose of this aim is to evaluate the effect of radiation dose on swallowing structures, applying a previously developed space-preserving NTCP approach based on principal component analysis (PCA).
Using this approach, dose distributions to the global swallowing apparatus (i.e. pharynx, larynx and esophagus) will be standardized for patients from both arms of Aim 1, using deformable registration to standardize organs and 3-D dose distributions to a common template. Dose distributions will be converted into a dose array and PCA will be applied to the dose array, as previously described. We will then use PC linear regression to identify eigenvectors significantly associated with long term dysphagia (as measured by PCR).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loren Mell, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loren Mell, MD, University of California, San Diego
- Investigators
- Loren K Mell, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359199
- Sponsor's protocol ID
- 190048
- Acronym
- QUASAR
- Status last verified
- Feb 2023
- First submitted
- 20 Apr 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14.
PubMed 26371282Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
PubMed 17081915Leonard R, Kendall K. Dysphagia Assessment and Treatment Planning: A Team Approach. Fourth. Plural Publishing; 2018
Stoeckli SJ, Huisman TA, Seifert B, Martin-Harris BJ. Interrater reliability of videofluoroscopic swallow evaluation. Dysphagia. 2003 Winter;18(1):53-7. doi: 10.1007/s00455-002-0085-0.
PubMed 12497197Yip H, Leonard R, Belafsky PC. Can a fluoroscopic estimation of pharyngeal constriction predict aspiration? Otolaryngol Head Neck Surg. 2006 Aug;135(2):215-7. doi: 10.1016/j.otohns.2006.03.016.
PubMed 16890070Leonard R, Rees CJ, Belafsky P, Allen J. Fluoroscopic surrogate for pharyngeal strength: the pharyngeal constriction ratio (PCR). Dysphagia. 2011 Mar;26(1):13-7. doi: 10.1007/s00455-009-9258-4. Epub 2009 Oct 24.
PubMed 19856026Servagi-Vernat S, Ali D, Roubieu C, Durdux C, Laccourreye O, Giraud P. Dysphagia after radiotherapy: state of the art and prevention. Eur Ann Otorhinolaryngol Head Neck Dis. 2015 Feb;132(1):25-9. doi: 10.1016/j.anorl.2013.09.006. Epub 2014 Jun 9.
PubMed 24924114Jensen K, Lambertsen K, Grau C. Late swallowing dysfunction and dysphagia after radiotherapy for pharynx cancer: frequency, intensity and correlation with dose and volume parameters. Radiother Oncol. 2007 Oct;85(1):74-82. doi: 10.1016/j.radonc.2007.06.004. Epub 2007 Jul 27.
PubMed 17673322Duprez F, Madani I, De Potter B, Boterberg T, De Neve W. Systematic review of dose--volume correlates for structures related to late swallowing disturbances after radiotherapy for head and neck cancer. Dysphagia. 2013 Sep;28(3):337-49. doi: 10.1007/s00455-013-9452-2. Epub 2013 Feb 22.
PubMed 23429941Liang Y, Messer K, Rose BS, Lewis JH, Jiang SB, Yashar CM, Mundt AJ, Mell LK. Impact of bone marrow radiation dose on acute hematologic toxicity in cervical cancer: principal component analysis on high dimensional data. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):912-9. doi: 10.1016/j.ijrobp.2009.11.062. Epub 2010 May 14.
PubMed 20472344Green G, Kim E, Carmona R, Shen H, Murphy JD, Mell LK. Incidence of Long-Term Esophageal Dilation With Various Treatment Approaches in the Older Head and Neck Cancer Population. Front Oncol. 2018 Oct 23;8:466. doi: 10.3389/fonc.2018.00466. eCollection 2018.
PubMed 30406032
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT04359199
- Acronym / sponsor ID
- QUASAR / 190048
- Conditions
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma
- Keywords
- head and neck cancer, oropharyngeal dysphagia, radiation therapy, immunotherapy, videofluoroscopic swallow study, modified barium swallow study, oropharynx cancer, oropharynx squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Loren Mell, MDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Apr 2020 (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.
To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab).
Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).
Detailed description
The QUASAR study will use a prospective, observational, cross sectional design (See Schema). HNC patients treated with definitive RT and immunotherapy or chemotherapy (cetuximab or cisplatin) will undergo VFSS at 4-6 and 12-24 months post-treatment. Patients enrolled prior to 6 months after finishing therapy will undergo a swallow study during the 4-6 month period AND the 12-24 month period. Patients enrolled after 6 months after finishing therapy will undergo a single swallow study in the 12-24 month period. The primary endpoint of PCR at 12-24 months will be compared between patients treated with immunotherapy versus chemotherapy.
All patients with HNC treated with definitive RT and systemic therapy at our institution will be eligible. In particular, we will recruit patients for this study from participants in two ongoing trials investigating the use of concurrent immunotherapy. The KEYCHAIN trial (ClinicalTrials.gov Identifier: NCT03383094) randomizes patients with locally advanced p16+ HNC undergoing definitive RT to concurrent q3 week cisplatin versus concurrent and adjuvant pembrolizumab. NRG-HN004 (ClinicalTrials.gov Identifier: NCT03258554) is a cooperative group trial that compares HNC patients that are not eligible for cisplatin undergoing definitive radiation therapy to concurrent cetuximab versus durvalumab.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy with chemotherapy | – | Radiation: Radiation Therapy, Drug: Cetuximab, Drug: ChemotherapyPatients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab) |
| Radiotherapy with immunotherapy | – | Radiation: Radiation Therapy, Drug: ImmunotherapyPatients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck carcinoma treated with definitive radiation therapy and systemic therapy (chemotherapy or immunotherapy) in the University of California San Diego Healthcare System will be eligible.
Key inclusion criteria (5 listed)
- Biopsy-proven, un-resected invasive carcinoma of the head and neck.
- Treated with definitive RT and concurrent systemic therapy or treated within the past 4-24 months
- Concurrent systemic therapy with Cisplatin, Cetuximab or immunotherapy.
- Age ≥ 18
- Able to understand and willing to sign a written informed consent.
Key exclusion criteria (3 listed)
- Prior radiotherapy that would result in overlap of planned radiation therapy fields.
- Prior systemic chemotherapy, unless as part of the coordinated plan of care for the treatment of the carcinoma (e.g., induction/neoadjuvant chemotherapy is allowed)
- Planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery
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 |
|---|---|---|
| Radiation TherapyAlso: radiotherapy, RTRoutine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer | Radiation | Radiotherapy with chemotherapy, Radiotherapy with immunotherapy |
| CetuximabAlso: ErbituxCetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of head and neck cancer | Drug | Radiotherapy with chemotherapy |
| ChemotherapyAlso: CisplatinCisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer | Drug | Radiotherapy with chemotherapy |
| ImmunotherapyAlso: pembrolizumab, Keytruda, nivolumab, OpdivoKeytruda or Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. Opdivo or Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody. Imfinzi or Durvalumab is an anti-cancer ("antineoplastic") drug. This medication is classified as an Anti-PD-L1 monoclonal antibody. | Drug | Radiotherapy with immunotherapy |
Primary outcome
Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR
Time frame: 12-24 months
will use a two-sample t-test at 0.05 level to compare Pharyngeal Constriction Ratio (PCR) between groups
3 secondary outcomes
Quantitative swallowing function at 4-6 months and 12-24 months by PCR, TPT, PRR and PPWT
Time frame: 4-6 months and 12-24 months
Correlation between quantitative swallowing function and patient reported symptoms using the EAT-10 tool
Time frame: 12-24 months
Correlation between radiation dose and location of swallowing function and quantitative swallowing function
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 26371282Naidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14.
- Background: PubMed 17081915Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
- BackgroundLeonard R, Kendall K. Dysphagia Assessment and Treatment Planning: A Team Approach. Fourth. Plural Publishing; 2018
- Background: PubMed 12497197Stoeckli SJ, Huisman TA, Seifert B, Martin-Harris BJ. Interrater reliability of videofluoroscopic swallow evaluation. Dysphagia. 2003 Winter;18(1):53-7. doi: 10.1007/s00455-002-0085-0.
- Background: PubMed 16890070Yip H, Leonard R, Belafsky PC. Can a fluoroscopic estimation of pharyngeal constriction predict aspiration? Otolaryngol Head Neck Surg. 2006 Aug;135(2):215-7. doi: 10.1016/j.otohns.2006.03.016.
- Background: PubMed 19856026Leonard R, Rees CJ, Belafsky P, Allen J. Fluoroscopic surrogate for pharyngeal strength: the pharyngeal constriction ratio (PCR). Dysphagia. 2011 Mar;26(1):13-7. doi: 10.1007/s00455-009-9258-4. Epub 2009 Oct 24.
- Background: PubMed 24924114Servagi-Vernat S, Ali D, Roubieu C, Durdux C, Laccourreye O, Giraud P. Dysphagia after radiotherapy: state of the art and prevention. Eur Ann Otorhinolaryngol Head Neck Dis. 2015 Feb;132(1):25-9. doi: 10.1016/j.anorl.2013.09.006. Epub 2014 Jun 9.
- Background: PubMed 17673322Jensen K, Lambertsen K, Grau C. Late swallowing dysfunction and dysphagia after radiotherapy for pharynx cancer: frequency, intensity and correlation with dose and volume parameters. Radiother Oncol. 2007 Oct;85(1):74-82. doi: 10.1016/j.radonc.2007.06.004. Epub 2007 Jul 27.
- Background: PubMed 23429941Duprez F, Madani I, De Potter B, Boterberg T, De Neve W. Systematic review of dose--volume correlates for structures related to late swallowing disturbances after radiotherapy for head and neck cancer. Dysphagia. 2013 Sep;28(3):337-49. doi: 10.1007/s00455-013-9452-2. Epub 2013 Feb 22.
- Background: PubMed 20472344Liang Y, Messer K, Rose BS, Lewis JH, Jiang SB, Yashar CM, Mundt AJ, Mell LK. Impact of bone marrow radiation dose on acute hematologic toxicity in cervical cancer: principal component analysis on high dimensional data. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):912-9. doi: 10.1016/j.ijrobp.2009.11.062. Epub 2010 May 14.
- Results publication: PubMed 30406032Green G, Kim E, Carmona R, Shen H, Murphy JD, Mell LK. Incidence of Long-Term Esophageal Dilation With Various Treatment Approaches in the Older Head and Neck Cancer Population. Front Oncol. 2018 Oct 23;8:466. doi: 10.3389/fonc.2018.00466. eCollection 2018.
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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.
Loren K Mell, MD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Dysphagia, run by Loren Mell, MD at 2 sites in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khusbu Singh, MBBS, CCRP (858-245-2604, ksingh@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359199, which also lists 11 linked publications.
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 Feb 2023.