Head and Neck CancerPhase 2DARTBOARDNCT04883281
A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
A Phase 2 study testing Intensity modulated radiation therapy (IMRT) with or without chemotherapy and cisplatin, cetuximab, or carboplatin-paclitaxel in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Intensity modulated radiation therapy (IMRT) with or without chemotherapy and cisplatin, cetuximab, or carboplatin-paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 11 Mar 2026
- Phase
- Phase 2
- 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
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
- Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
- ECOG Performance Status 0-2
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- Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
- Ability to understand and the willingness to sign a written informed consent.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- Distant metastasis.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met.
- Prior invasive malignancy with an expected disease-free interval of less than 3 years.
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- Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- Subjects may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- pregnant or nursing women
- History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: DARTBOARD: A Prospective Randomized Phase II Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. This system is commercially-available and FDA-approved, and UTSW Radiation Oncology has installed two such units. The ability to adjust the dose delivery every day means both that adaptive therapy is possible with every fraction and that the PTV margin can be dramatically reduced/eliminated, since investigators are treating for that day's patient setup. Investigators are therefore proposing a randomized trial using DART with near marginless (ML) setup margins (a 1 mm margin will be retained for intrafractional motion).
Read the detailed description
IMRT with daily cone-beam computed tomography (CBCT) set up is the current recommended radiation technique for head and neck squamous cell carcinoma. The conformality of IMRT has made it possible to reduce dose to normal tissues, but it also predisposes the treatments to drastic delivered dose deviations due to changes in the patient (e.g. weight loss, muscle atrophy, or normal tissue edema) or in the tumor (e.g. treatment response or treatment related edema). These changes can create poor coverage and/or cold spots in the tumor and increased coverage and/or hot spots in the normal organs at risk. Image guidance with CBCTs can help reduce set up error between treatments, but image guidance can't adjust for these patient or tumor changes.
Adaptive radiotherapy (ART) is the process of replanning the patient's radiation plan by adjusting the target structures, organs at risk structures, and optimal radiation delivery during the radiation therapy course. ART allows treating physicians to account for all the patient or tumor changes that can't be currently resolved with image guidance. Previously, ART was a prohibitively resource and time-consuming process that could only be performed once or twice during a conventional 6.5 to 7-week head and neck radiation treatment course in select patients with substantial structural changes. However, with the recent advent of adaptive software, ART can now be performed on a daily basis.
The data on the possible advantages of ART in head and neck cancer is still limited to small, mostly pre-clinical studies. In a feasibility study, five patients with locally advanced HPV-positive oropharynx cancer undergoing definitive chemoradiation underwent an MRI every two weeks during their treatment. The results showed an average decrease in the primary tumor GTV volume of 44%, 90%, and 100% and an average decrease in the nodal GTV volume of 25%, 60%, and 80% by at weeks 2, 4, and 6 weeks, respectively. Another similar study on eight patients saw an average 70% GTV volume reduction by week 6.
In addition to tumor coverage, parotid glands are of particular interest in ART because of their radiosensitivity and association with xerostomia and decreased quality of life. Toxicity of salivary glands are related to dose as a continuous variable, so even modest decreases in dose can have a clinical impact. The average volume of the parotids has been reported to decrease as much as 14.7%, 37%, and 48% by the end of weeks 2, 4, and 7. The parotid glands also appear to shift superiorly and medially during treatment. Feasibility ART studies have shown that the dose to the parotid may decrease by as much as 5.5 Gy with ART. Therefore ART holds the promise of preserving the expected dose distribution to salivary OARs, improving long-term patient outcomes.
The ability to ensure coverage of the target structures and proper avoidance of organs at risk on a daily basis also greatly improves the confidence of the daily set-up and targeting. Current recommended radial PTV margins with daily CBCT are 3-5 mm, with even larger margins recommended for patients at risk of larger inter-fraction variability. These PTV margins are built to ensure the disease is not missed by the treatment due to daily setup error. However, these margins also significantly increase the irradiated volume, since the volume increases exponentially with each additional millimeter. Therefore, decreasing margins, even by a few millimeters, can results in large changes in treatment volume and improvement in toxicity.
In a retrospective Danish analysis of patients treated with 5 mm versus 3 mm PTV margins, Navran et al. noted that acute grade 3 toxicity (65% vs 53.8%, p = 0.008) and late grade 3 dysphagia (20.4% vs 11.1%, p = 0.012) were significantly lower in the smaller margin group. There were no differences in disease outcomes between the two groups. In a retrospective study analyzing the benefit of changing the margin on gross disease from 8 mm to 5 mm, just a 3 mm difference, Samuels et al. found that plans with the smaller PTV margin had a clinically meaningful improvement in the normal tissue complication probability for the ipsilateral parotid gland and contralateral submandibular gland when compared to conventional PTV margin plans. In fact, 40% of patients would have theoretically experienced an improvement in the function of both of these glands, just by modestly shrinking the PTV.
- Conditions
- Head and Neck Cancer
- Being tested
- Intensity modulated radiation therapy (IMRT) with or without chemotherapy, cisplatin, cetuximab, or carboplatin-paclitaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiation therapy (IMRT) with or without chemotherapyRadiation
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
cisplatin, cetuximab, or carboplatin-paclitaxelDrug
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
| Study group | Role | What they receive |
|---|---|---|
| Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy | Active comparator | If a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV. Receives: Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy; Drug: cisplatin, cetuximab, or carboplatin-paclitaxel |
| Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy | Experimental | Patients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician. Receives: Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy; Drug: cisplatin, cetuximab, or carboplatin-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia Questionnaire (XQ)
1-year score on the Xerostomia Questionnaire (XQ) to determine the difference in chronic xerostomia between patients treated with conventional INRT versus ML DART INRT. The XQ score at one year will be compared between the arms using a two-sided t test.
Measured: 1 year
Secondary outcomes (3)
Development of acute and chronic toxicity in patients treated with and without DART
Incidence of acute grade 2+ radiation dermatitis, acute and chronic grade 3+ dysphagia, acute grade 3+ mucositis, and chronic grade 2+ soft tissue and osteonecrosis. Each toxicity endpoint will be compared between the arms using a Fisher exact test.
Measured: 1 year
Risk of locoregional recurrence with and without DART
Cumulative incidence of locoregional recurrence, as confirmed by biopsy. The cumulative incidence of locoregional and distant failure will be estimated using cumulative incidence statistics, with death serving as the competing risk. The two arms will be compared using Gray's test.
Measured: 1 year
Patient reported outcomes
Patient Reported Outcomes (PRO): EORTC QLQ-30 Global Score, EORTC HN 35 Pain and Senses Scores, MDADI Composite Score Each of the patient reported outcomes are single numeric scores that are collected at baseline, 1, 3, 6, and 12 months from treatment. Patients with disease recurrence will be excluded. At each individual time point, the differences between the arms in the changes of these outcomes between baseline to that timepoint will be compared using a t-test and analyzed longitudinally using generalized estimated equations (GEE).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start23 Feb 2022
- Primary completion4 Sep 2024
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sher, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883281
- Sponsor's protocol ID
- STU-2021-0401
- Acronym
- DARTBOARD
- Status last verified
- Sep 2024
- First submitted
- 27 Apr 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sher DJ, Avkshtol V, Lin MH, Wang J, Chen L, Liao CY, Hughes R, Domal S, Ahn C, Moon DH. Impact of daily adaptive head and neck radiotherapy on toxicity and quality of life: results of the DARTBOARD phase II randomized trial. J Natl Cancer Inst. 2025 Dec 1;117(12):2488-2494. doi: 10.1093/jnci/djaf232.
PubMed 40833933
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DARTBOARD: A Prospective Randomized Phase II Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04883281
- Acronym / sponsor ID
- DARTBOARD / STU-2021-0401
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 12 May 2021 (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.
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. This system is commercially-available and FDA-approved, and UTSW Radiation Oncology has installed two such units. The ability to adjust the dose delivery every day means both that adaptive therapy is possible with every fraction and that the PTV margin can be dramatically reduced/eliminated, since investigators are treating for that day's patient setup. Investigators are therefore proposing a randomized trial using DART with near marginless (ML) setup margins (a 1 mm margin will be retained for intrafractional motion).
Detailed description
IMRT with daily cone-beam computed tomography (CBCT) set up is the current recommended radiation technique for head and neck squamous cell carcinoma. The conformality of IMRT has made it possible to reduce dose to normal tissues, but it also predisposes the treatments to drastic delivered dose deviations due to changes in the patient (e.g. weight loss, muscle atrophy, or normal tissue edema) or in the tumor (e.g. treatment response or treatment related edema). These changes can create poor coverage and/or cold spots in the tumor and increased coverage and/or hot spots in the normal organs at risk. Image guidance with CBCTs can help reduce set up error between treatments, but image guidance can't adjust for these patient or tumor changes.
Adaptive radiotherapy (ART) is the process of replanning the patient's radiation plan by adjusting the target structures, organs at risk structures, and optimal radiation delivery during the radiation therapy course. ART allows treating physicians to account for all the patient or tumor changes that can't be currently resolved with image guidance. Previously, ART was a prohibitively resource and time-consuming process that could only be performed once or twice during a conventional 6.5 to 7-week head and neck radiation treatment course in select patients with substantial structural changes. However, with the recent advent of adaptive software, ART can now be performed on a daily basis.
The data on the possible advantages of ART in head and neck cancer is still limited to small, mostly pre-clinical studies. In a feasibility study, five patients with locally advanced HPV-positive oropharynx cancer undergoing definitive chemoradiation underwent an MRI every two weeks during their treatment. The results showed an average decrease in the primary tumor GTV volume of 44%, 90%, and 100% and an average decrease in the nodal GTV volume of 25%, 60%, and 80% by at weeks 2, 4, and 6 weeks, respectively. Another similar study on eight patients saw an average 70% GTV volume reduction by week 6.
In addition to tumor coverage, parotid glands are of particular interest in ART because of their radiosensitivity and association with xerostomia and decreased quality of life. Toxicity of salivary glands are related to dose as a continuous variable, so even modest decreases in dose can have a clinical impact. The average volume of the parotids has been reported to decrease as much as 14.7%, 37%, and 48% by the end of weeks 2, 4, and 7. The parotid glands also appear to shift superiorly and medially during treatment. Feasibility ART studies have shown that the dose to the parotid may decrease by as much as 5.5 Gy with ART. Therefore ART holds the promise of preserving the expected dose distribution to salivary OARs, improving long-term patient outcomes.
The ability to ensure coverage of the target structures and proper avoidance of organs at risk on a daily basis also greatly improves the confidence of the daily set-up and targeting. Current recommended radial PTV margins with daily CBCT are 3-5 mm, with even larger margins recommended for patients at risk of larger inter-fraction variability. These PTV margins are built to ensure the disease is not missed by the treatment due to daily setup error. However, these margins also significantly increase the irradiated volume, since the volume increases exponentially with each additional millimeter. Therefore, decreasing margins, even by a few millimeters, can results in large changes in treatment volume and improvement in toxicity.
In a retrospective Danish analysis of patients treated with 5 mm versus 3 mm PTV margins, Navran et al. noted that acute grade 3 toxicity (65% vs 53.8%, p = 0.008) and late grade 3 dysphagia (20.4% vs 11.1%, p = 0.012) were significantly lower in the smaller margin group. There were no differences in disease outcomes between the two groups. In a retrospective study analyzing the benefit of changing the margin on gross disease from 8 mm to 5 mm, just a 3 mm difference, Samuels et al. found that plans with the smaller PTV margin had a clinically meaningful improvement in the normal tissue complication probability for the ipsilateral parotid gland and contralateral submandibular gland when compared to conventional PTV margin plans. In fact, 40% of patients would have theoretically experienced an improvement in the function of both of these glands, just by modestly shrinking the PTV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy | Active comparator | Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy, Drug: cisplatin, cetuximab, or carboplatin-paclitaxelIf a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV. |
| Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy | Experimental | Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy, Drug: cisplatin, cetuximab, or carboplatin-paclitaxelPatients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
- Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
Key exclusion criteria (13 listed)
- Distant metastasis.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met.
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 |
|---|---|---|
| Intensity modulated radiation therapy (IMRT) with or without chemotherapyIntensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) | Radiation | Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy, Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy |
| cisplatin, cetuximab, or carboplatin-paclitaxelchemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) | Drug | Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy, Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy |
Primary outcome
Xerostomia Questionnaire (XQ)
Time frame: 1 year
1-year score on the Xerostomia Questionnaire (XQ) to determine the difference in chronic xerostomia between patients treated with conventional INRT versus ML DART INRT. The XQ score at one year will be compared between the arms using a two-sided t test.
3 secondary outcomes
Development of acute and chronic toxicity in patients treated with and without DART
Time frame: 1 year
Risk of locoregional recurrence with and without DART
Time frame: 1 year
Patient reported outcomes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 40833933Sher DJ, Avkshtol V, Lin MH, Wang J, Chen L, Liao CY, Hughes R, Domal S, Ahn C, Moon DH. Impact of daily adaptive head and neck radiotherapy on toxicity and quality of life: results of the DARTBOARD phase II randomized trial. J Natl Cancer Inst. 2025 Dec 1;117(12):2488-2494. doi: 10.1093/jnci/djaf232.
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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 Phase 2 study testing Intensity modulated radiation therapy (IMRT) with or without chemotherapy and cisplatin, cetuximab, or carboplatin-paclitaxel in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 1 site 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 13 inclusion and 13 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 18 Mar 2026. 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 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Xerostomia Questionnaire (XQ) (time frame: 1 year). 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 NCT04883281, which also lists 1 linked publication.
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 18 Mar 2026.