Head and Neck CancerARMORNCT03843554
Commensal Oral Microbiota in Head and Neck Cancer
A study testing Oral mucosal deterging and dental prophylaxis in people with Head and Neck Cancer and Oral Mucositis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis
- What is being tested?
- Oral mucosal deterging and dental prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 3 Aug 2022
- Phase
- Interventional
- 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
Currently enrolling subjects receiving intensity-modulated radiation therapy (IMRT), with or without chemotherapy.
Subject Inclusion Criteria
To participate in this study, an individual must meet all the following criteria:
- 18 years of age or older;
- Able and willing to provide informed consent prior to initiation of study procedures;
- Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
- Presents with at least one of nine areas of the oral or oropharyngeal mucosa (i.e., upper lip, lower lip, right cheek, left cheek, right ventral and lateral tongue, left ventral and lateral tongue, floor of the mouth, and soft palate) expected to receive at least 5000 cGy of RT. Patients with cancer located outside of the oral cavity will be included when at least 5000 cGy of RT will be administered to the oral cavity in addition to the RT targeted at the primary cancer site.
- Presents with a minimum of 6 natural teeth.
Subject Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or lactating at the baseline/screening visit;
- Participating in another oral health interventional research study at any point during their participation in this trial;
- Receiving induction chemotherapy or concurrent radiation therapy with cetuximab;
- Reports current use of antifungal or antibiotic at the time of enrollment;
- Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000);
- Presents with any of the following conditions, which based on American Dental and American College of Cardiology guidelines, require antibiotic prophylaxis prior to dental treatment:
- prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts;
- prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords;
- a history of infective endocarditis;
- a cardiac transplant with valve regurgitation due to a structurally abnormal valve;
- the following congenital (present from birth) heart disease: unrepaired cyanotic congenital heart disease, including palliative shunts and conduits; or any repaired congenital heart defect with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or a prosthetic device;
- Presents with cardiovascular implantable electronic devices (CIEDs) such as pacemakers, and implantable cardioverter-defibrillators; unless, a) in the opinion of the investigator, the OMDP protocol can be performed with hand scalers (and not with an ultrasonic device as per protocol) or upon consult with the treating cardiologist, it is determined that the ultrasonic device can be safely used;
- Presents with severe periodontal disease for which treatment cannot be completed prior to the start of radiation/chemoradiation (at the discretion of the investigator);
- Had surgery as part of cancer treatment and is not sufficiently healed to comply with study requirements prior to RT initiation;
- In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity
The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.
Read the detailed description
This is a prospective, single blind, two arm, randomized, controlled trial to test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial will also measure salivary proinflammatory cytokines, and evaluate other clinical effects of the intervention during cancer therapy. In addition, oral mucosal swabs will be collected for the future characterization of changes in the microbiome associated with OM severity.
Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to start of RT or chemoRT to ensure that all subjects enter the study with comparable oral health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will receive oral health instructions following the American Dental Association Guidelines and will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to the oral mucosa will be provided to this group.
At each bi-weekly study visit, study assessments will include the collection of saliva and oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires. During the course of the study, subjects will attend one baseline visit, up to 9 intervention visits, and a follow-up visit approximately 3 months after completion of RT. Local supportive care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. Magic Mouthwash), feeding tubes, and pain management will be allowed according to each recruitment site's standard of care procedures.
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Being tested
- Standard of Care Oral Hygiene, Oral mucosal deterging and dental prophylaxis
- Keywords
- Head Cancer, Neck Cancer, Oral Mucositis, Oral Health, Radiation, Chemoradiation
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Oral HygieneOther
Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.
Oral mucosal deterging and dental prophylaxisProcedure or surgery
Subjects will receive a professional dental prophylaxis including periodontal surface debridement [a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum] and deterging of the oral mucosal surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Oral Hygiene | Placebo comparator | Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. Receives: Other: Standard of Care Oral Hygiene |
| Oral Mucosal Deterging and Dental Prophylaxis (OMDP) | Experimental | Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. Receives: Procedure: Oral mucosal deterging and dental prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Mucosal Severity (Grade 3 or 4)
World Health Organization's Oral Toxicity Scale (WHO OTS): Oral mucositis severity as measured by the WHO OTS; severity is graded 0 through 4, with 4 being the worst. Grade 0 (none), Grade 1 (oral soreness, erythema), Grade 2 (ulceration, solid diet tolerated), Grade 3 (ulceration, liquid diet only), and Grade 4 (nothing by mouth).
Measured: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
Secondary outcomes (5)
Inflammatory Markers Correlative Measures
Salivary cytokines: Levels of Th1/Th2-type cytokines IL10, IL8, IL12p70, TNF alpha, IL4, IL1b, IL2, IL13, IL5, and IFN gamma will be assessed, in addition to levels of gp340.
Measured: Baseline and final intervention visit.
Duration of OM Severity
OM severity (Grade 3 or more) was measured by a blinded member of the study team using the WHO OTS (previously described) and the duration and time to onset of severe OM measured in days.
Measured: Baseline and visits 1-9 interval during radiation therapy (area under the curve).
Salivary Hypofunction
Saliva flow rate (mL/minute) from baseline to subsequent visits was assessed by a 5-minute stimulated saliva collection. The outcome analyzed was the change from baseline to subsequent visits in saliva.
Measured: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
Pain Scores
The average pain of OM was measured subjectively (visual analog scale 0-10) and obtained by having subjects complete a questionnaire with questions based on an eleven-point numeric scale regarding oral pain (0 being no pain and 10 being maximum pain).
Measured: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
QOL and Function
Quality of life and function was assessed using the validated EORTC-QLQ-C30 for head and neck cancers. This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth). The analysis was focused on EORTC-QLC30 Questions 31 through 48. High scores indicate better QOL. High scores for the Sypmton Scale are indicative of deterioration.
Measured: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start23 Sep 2019
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Why it stopped: Study was terminated with 50% enrollment by the sponsor due to under enrollment into specific diverse racial, ethnic, and sex/gender categories. https://grants.nih.gov/policy/inclusion/women-and-minorities.htm
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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single blind, two arm, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, The Forsyth Institute, Medical University of South Carolina, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Patricia Corby, DDS, University of Pennsylvania
- Investigators
- Patricia Corby, DDS, Principal investigator, University of PennsylvaniaAlex Lin, MD, Principal investigator, Penn Medicine, Perelman Center for Advanced Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843554
- Sponsor's protocol ID
- 832750
- Other IDs
- U01DE027637, UPCC 06319
- Acronym
- ARMOR
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2019
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ARMOR Trial: Commensal Oral Microbiota as a Trigger of Oral Mucositis Severity
- ClinicalTrials.gov ID
- NCT03843554
- Acronym / sponsor ID
- ARMOR / 832750
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Keywords
- Head Cancer, Neck Cancer, Oral Mucositis, Oral Health, Radiation, Chemoradiation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated with 50% enrollment by the sponsor due to under enrollment into specific diverse racial, ethnic, and sex/gender categories. https://grants.nih.gov/policy/inclusion/women-and-minorities.htm
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- NYU Langone Health, The Forsyth Institute, Medical University of South Carolina, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.
Detailed description
This is a prospective, single blind, two arm, randomized, controlled trial to test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial will also measure salivary proinflammatory cytokines, and evaluate other clinical effects of the intervention during cancer therapy. In addition, oral mucosal swabs will be collected for the future characterization of changes in the microbiome associated with OM severity.
Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to start of RT or chemoRT to ensure that all subjects enter the study with comparable oral health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will receive oral health instructions following the American Dental Association Guidelines and will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to the oral mucosa will be provided to this group.
At each bi-weekly study visit, study assessments will include the collection of saliva and oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires. During the course of the study, subjects will attend one baseline visit, up to 9 intervention visits, and a follow-up visit approximately 3 months after completion of RT. Local supportive care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. Magic Mouthwash), feeding tubes, and pain management will be allowed according to each recruitment site's standard of care procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single blind, two arm, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Oral Hygiene | Placebo comparator | Other: Standard of Care Oral HygieneStandard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home. |
| Oral Mucosal Deterging and Dental Prophylaxis (OMDP) | Experimental | Procedure: Oral mucosal deterging and dental prophylaxisOral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard of Care Oral HygieneStandard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing. | Other | Standard of Care Oral Hygiene |
| Oral mucosal deterging and dental prophylaxisSubjects will receive a professional dental prophylaxis including periodontal surface debridement [a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum] and deterging of the oral mucosal surfaces. | Procedure or surgery | Oral Mucosal Deterging and Dental Prophylaxis (OMDP) |
Primary outcome
Oral Mucosal Severity (Grade 3 or 4)
Time frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
World Health Organization's Oral Toxicity Scale (WHO OTS): Oral mucositis severity as measured by the WHO OTS; severity is graded 0 through 4, with 4 being the worst. Grade 0 (none), Grade 1 (oral soreness, erythema), Grade 2 (ulceration, solid diet tolerated), Grade 3 (ulceration, liquid diet only), and Grade 4 (nothing by mouth).
5 secondary outcomes
Inflammatory Markers Correlative Measures
Time frame: Baseline and final intervention visit.
Duration of OM Severity
Time frame: Baseline and visits 1-9 interval during radiation therapy (area under the curve).
Salivary Hypofunction
Time frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
Pain Scores
Time frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
QOL and Function
Time frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Patricia Corby, DDS principal investigator
University of Pennsylvania
Alex Lin, MD principal investigator
Penn Medicine, Perelman Center for Advanced Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral mucosal deterging and dental prophylaxis in people with Head and Neck Cancer and Oral Mucositis, run by University of Pennsylvania 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?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2025. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). 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?
Oral Mucosal Severity (Grade 3 or 4) (time frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0).). 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 26 Sep 2025.