Radiation MucositisPhase 2SNIFFNCT07524894
Staph Nasal Decolonization to Improve Function and Feeding
A Phase 2 study testing Mupirocin Ointment [Treatment] in people with Radiation Mucositis and Staphylococcal Aureus Infection, run by David Palma at 1 site in Canada.
Trial summary
Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Mucositis, Staphylococcal Aureus Infection, Head and Neck Cancer
- What is being tested?
- Mupirocin Ointment [Treatment]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 30 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed mucosal squamous cell carcinoma of the head and neck, planned to receive a dose equivalent to 60 Gy in 30 fractions or higher, with or without concurrent systemic treatment. This can include hypofractionated regimens of 55 Gy in 20 fractions. Primary sites considered: oral cavity, oropharynx, larynx (excluding T1-T2N0 glottic cancers), hypopharynx. The radiotherapy treatment planned can be definitive or adjuvant.
- Age ≥18 years.
- ECOG performance status 0-2
- Informed consent provided.
Who cannot join
- Mupirocin allergy
- Skin or salivary gland malignancy
- Early stage glottic cancers (T1-2N0)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
London Health Sciences Centre
London, Ontario, N6A5W9
Niall O'Dwyer, MD, +1 5196858500, niall.odwyer@lhsc.on.ca
David Palma, MD PhD, +1 5196858500, david.palma@lhsc.on.ca
About this study
Official title: Staph Nasal Decolonization to Improve Function and Feeding: A Randomized Clinical Trial (SNIFF)
Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Patients with head and neck cancer are commonly treated with radiation, sometimes after surgery and sometimes the radiation is delivered with chemotherapy at the same time. Radiation treatments have side effects, and the treating oncologist works with each patient to determine the best treatment and manage the side effects.
It has been shown that one of these side effects of radiation is irritation or "sunburn" of the lining of the mouth and throat (radiation mucositis), which can cause difficult or painful swallowing, and pain/discomfort in the mouth/throat. These side effects can lead to dehydration, and weight loss, and sometimes can lead to hospital admissions and treatment delays. This is usually treated by the prescription of pain relievers, dietician support and, if necessary, nutrition via a tube (G-tube).
Because of these symptoms involving the mouth and throat, researchers are looking to study the effect of a common ointment antibiotic used to reduce an infection known as Staphylococcus Aureus. The infection is commonly located in the front of the nose, and during treatment this infection can travel from the nose to the throat and worsen the radiation mucositis and the pain it causes. The study will measure if a course of ointment antibiotic in the nose (twice per day, 5 days on, 5 days off, repeated) can reduce your pain during treatment by reducing severe mucositis related to Staphylococcal infection. This study compares the effects of the study treatment with a "placebo," which looks the same but does not contain any active medicine. Neither you nor your doctor will know which one you are receiving until the study ends. The antibiotic used in the study arm is being used "off-label" for intranasal application (it is normally used to treat skin infections). Possible side effects include local skin irritation or allergic reactions, and in rare cases, a severe allergic response (anaphylaxis).
Read the detailed description
Radiation induced oral mucositis (RIOM) is a significant toxicity associated with curative head and neck radiotherapy leading to burdensome pain, weight loss, treatment interruptions and high healthcare utilisation. With contemporary treatment grade 3 or higher (CTCAE) oral mucositis rates occur in ~40% of all patients despite standardised oral care and supportive measures. There is growing evidence to implicate Staphylococcus aureus as a contributor to mucosal injury and symptom severity in this setting.
Skin and nasal carriage of S. aureus is common in the general population. In oncology patients auto-inoculation to the pharynx from the nose during treatment is biologically plausible. Intranasal antibiotics such as mupirocin are well-established, targeted decolonisation agents with a favourable safety profile when used intermittently, however their role in preventing severe radiation induced mucositis remains unknown.
Given RIOM typically emerges during weeks 2-3 of treatment and peaks towards the final treatment a cyclical short-course of intranasal or topical antibiotic regimen may sustain decolonisation across the vulnerable window while limiting continuous antibiotic exposure and potential resistance selection. The Centres for Disease Control and Protection recommend intranasal mupirocin when implementing decolonisation or pathogen reduction strategies for high risk patients during high risk periods.
A recent single-centre phase 3 randomised trial of 176 nasopharynx patients demonstrated a 25% reduction in grade 3 or higher oral mucositis rates when treated with cyclical nasal mupirocin decolonisation. This evidence led us to our research question- is this result applicable in a more generalised head and neck cancer population? SNIFF is a pragmatically designed randomised, placebo-controlled trial to test whether cyclical intranasal antibiotic reduces patient reported pain outcomes (NRS scale 0-10 measured weekly) due to reduction in rates of severe mucositis in patients receiving curative-intent head and neck radiotherapy (oral cavity, oropharynx, locally- advanced larynx, hypopharynx). The trial will also evaluate its effects on analgesia adjusted pain scores, physician reported mucositis rates patient reported quality of life (QOL) and rates of feeding tubes or treatment interruptions.
Please note: This trial will be run in a single centre (LHSC, London, Ontario)- the medication used in the experimental arm is topical Mupirocin 2% ointment, as the nasal form is not marketed in Canada. As the medication is being used off-label, we have applied to Health Canada via a Clinical Trial Application, and received a No-objection letter on Jan 14th 2026 (Health Canada control number 304222).
- Being tested
- Mupirocin Ointment [Treatment], Placebo
- 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.
Mupirocin Ointment [Treatment]Drug
1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment
PlaceboDrug
1 fingertip unit of topical petrolatum ointment (placebo) applied BID to both nares in cyclical week on/off fashion throughout radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin topical ointment | Experimental | 1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment Receives: Drug: Mupirocin Ointment [Treatment] |
| Placebo Arm | Placebo comparator | 1 fingertip unit of placebo petrolatum ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported pain (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain))
Severity of pain in mouth or throat, measured on a 0-10 pain scale. Assessed weekly during treatment, using worst noted pain across treatment duration for analysis
Measured: Measured weekly for duration of radiation treatment (Maximum 7 weeks)
Secondary outcomes (6)
Oral mucositis grade (Radiation Therapy Oncology Group scale 1-4 (Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support))
The RTOG (Radiation Therapy Oncology Group) mucositis grading scale evaluates radiation-induced oral mucositis severity in four stages. It ranges from Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support). This will be measured weekly by physician/nurse specialist
Measured: Weekly for duration of radiation (Max 7 weeks)
Quality of life score
The MDASI-HN (M. D. Anderson Symptom Inventory-Head and Neck) is a 28-item, patient-reported tool measuring symptom severity (0-10 scale) and daily life interference for head and neck cancer patients. It covers 13 core symptoms, 9 head/neck-specific items (e.g., dry mouth, swallowing), and 6 interference items . 0-10 Scale: Each item is rated from 0 ("not present") to 10 ("as bad as you can imagine"). The maximum total score for the 28 items is 280, with a specific focus on 9 Head \& Neck items (maximum 90).The score will be measured at treatment start and in final week of treatment
Measured: Measured at treatment start and in final week of treatment (Max 7 weeks)
Treatment interruptions
Any treatment interruptions measured at weekly assessment
Measured: Any treatment interruptions measured at weekly assessment (Max 7 weeks)
Feeding tube insertion
Any feeding tube insertion measured at weekly assessment
Measured: Any feeding tube insertion measured at weekly assessment (Max 7 weeks)
Hospital admissions
Any hospital admissions measured at weekly assessment
Measured: Any hospital admissions measured at weekly assessment (Max 7 weeks)
Morphine adjusted pain score (MAPS)
Exploratory outcome: Pain scores corrected for analgesia use using the novel Morphine-Adjusted Pain Scale (MAPS). Any morphine dosing measured at weekly patient review, converted to morphine equivalent dosing (MED) and Pain score (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain)) adjusted as below:
- MED dose 1-50mg: add 1 point to pain score (max score 10)
- MED dose 51-100mg: add 2 points to pain score (max score 10)
- MED 100mg+ : add 3 points to pain score (max score 10)
Measured: Measured weekly during radiotherapy treatment (Max 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
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 Radiation MucositisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group, randomized, double-blinded trial. Patients will be randomised in a 1:1 ratio to either arm. Arm 1: Intranasal Mupirocin BID to each naris, applied twice daily, to be commenced in first week of treatment on 7-day on/7-day off cycle until completion of treatment. Arm 2: Placebo, matching intranasal ointment base, applied on same schedule as Arm 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Palma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Palma, MD PhD, Principal investigator, London Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524894
- Sponsor's protocol ID
- SNIFF-ON-LHSC-001
- Acronym
- SNIFF
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcomes will be shared, including weekly odynophagia 11-point numeric rating scale scores, Radiation Therapy Oncology Group mucositis grades, MD Anderson Symptom Inventory scores, morphine-equivalent analgesia data and the derived analgesia-adjusted pain score, and key clinical outcomes (treatment interruptions, feeding tube insertion, hospital admissions), along with baseline demographic and treatment descriptors needed to interpret the dataset (e.g., age group, sex, primary site group, treatment intent, and concurrent systemic therapy category), and adverse event data; no direct identifiers will be shared.
Publications
Liao Z, Xiong X, Zhao L, Zhang Z, Guan C, Zhang L, Zhong F, Rao J, Wang X, Xiao Y, Gong X, Huang SH, Li J, Lu T. Bacterial Decolonization With Mupirocin Ointment for Acute Radiation Oral Mucositis Prevention: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 1;11(10):1141-1149. doi: 10.1001/jamaoncol.2025.2361.
PubMed 40773220
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staph Nasal Decolonization to Improve Function and Feeding: A Randomized Clinical Trial (SNIFF)
- ClinicalTrials.gov ID
- NCT07524894
- Acronym / sponsor ID
- SNIFF / SNIFF-ON-LHSC-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- David PalmaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Patients with head and neck cancer are commonly treated with radiation, sometimes after surgery and sometimes the radiation is delivered with chemotherapy at the same time. Radiation treatments have side effects, and the treating oncologist works with each patient to determine the best treatment and manage the side effects.
It has been shown that one of these side effects of radiation is irritation or "sunburn" of the lining of the mouth and throat (radiation mucositis), which can cause difficult or painful swallowing, and pain/discomfort in the mouth/throat. These side effects can lead to dehydration, and weight loss, and sometimes can lead to hospital admissions and treatment delays. This is usually treated by the prescription of pain relievers, dietician support and, if necessary, nutrition via a tube (G-tube).
Because of these symptoms involving the mouth and throat, researchers are looking to study the effect of a common ointment antibiotic used to reduce an infection known as Staphylococcus Aureus. The infection is commonly located in the front of the nose, and during treatment this infection can travel from the nose to the throat and worsen the radiation mucositis and the pain it causes. The study will measure if a course of ointment antibiotic in the nose (twice per day, 5 days on, 5 days off, repeated) can reduce your pain during treatment by reducing severe mucositis related to Staphylococcal infection. This study compares the effects of the study treatment with a "placebo," which looks the same but does not contain any active medicine. Neither you nor your doctor will know which one you are receiving until the study ends. The antibiotic used in the study arm is being used "off-label" for intranasal application (it is normally used to treat skin infections). Possible side effects include local skin irritation or allergic reactions, and in rare cases, a severe allergic response (anaphylaxis).
Detailed description
Radiation induced oral mucositis (RIOM) is a significant toxicity associated with curative head and neck radiotherapy leading to burdensome pain, weight loss, treatment interruptions and high healthcare utilisation. With contemporary treatment grade 3 or higher (CTCAE) oral mucositis rates occur in ~40% of all patients despite standardised oral care and supportive measures. There is growing evidence to implicate Staphylococcus aureus as a contributor to mucosal injury and symptom severity in this setting.
Skin and nasal carriage of S. aureus is common in the general population. In oncology patients auto-inoculation to the pharynx from the nose during treatment is biologically plausible. Intranasal antibiotics such as mupirocin are well-established, targeted decolonisation agents with a favourable safety profile when used intermittently, however their role in preventing severe radiation induced mucositis remains unknown.
Given RIOM typically emerges during weeks 2-3 of treatment and peaks towards the final treatment a cyclical short-course of intranasal or topical antibiotic regimen may sustain decolonisation across the vulnerable window while limiting continuous antibiotic exposure and potential resistance selection. The Centres for Disease Control and Protection recommend intranasal mupirocin when implementing decolonisation or pathogen reduction strategies for high risk patients during high risk periods.
A recent single-centre phase 3 randomised trial of 176 nasopharynx patients demonstrated a 25% reduction in grade 3 or higher oral mucositis rates when treated with cyclical nasal mupirocin decolonisation. This evidence led us to our research question- is this result applicable in a more generalised head and neck cancer population? SNIFF is a pragmatically designed randomised, placebo-controlled trial to test whether cyclical intranasal antibiotic reduces patient reported pain outcomes (NRS scale 0-10 measured weekly) due to reduction in rates of severe mucositis in patients receiving curative-intent head and neck radiotherapy (oral cavity, oropharynx, locally- advanced larynx, hypopharynx). The trial will also evaluate its effects on analgesia adjusted pain scores, physician reported mucositis rates patient reported quality of life (QOL) and rates of feeding tubes or treatment interruptions.
Please note: This trial will be run in a single centre (LHSC, London, Ontario)- the medication used in the experimental arm is topical Mupirocin 2% ointment, as the nasal form is not marketed in Canada. As the medication is being used off-label, we have applied to Health Canada via a Clinical Trial Application, and received a No-objection letter on Jan 14th 2026 (Health Canada control number 304222).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group, randomized, double-blinded trial. Patients will be randomised in a 1:1 ratio to either arm. Arm 1: Intranasal Mupirocin BID to each naris, applied twice daily, to be commenced in first week of treatment on 7-day on/7-day off cycle until completion of treatment. Arm 2: Placebo, matching intranasal ointment base, applied on same schedule as Arm 1.
| Arm | Type | Receives |
|---|---|---|
| Mupirocin topical ointment | Experimental | Drug: Mupirocin Ointment [Treatment]1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment |
| Placebo Arm | Placebo comparator | Drug: Placebo1 fingertip unit of placebo petrolatum ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed mucosal squamous cell carcinoma of the head and neck, planned to receive a dose equivalent to 60 Gy in 30 fractions or higher, with or without concurrent systemic treatment. This can include hypofractionated regimens of 55 Gy in 20 fractions. Primary sites considered: oral cavity, oropharynx, larynx (excluding T1-T2N0 glottic cancers), hypopharynx. The radiotherapy treatment planned can be definitive or adjuvant.
- Age ≥18 years.
- ECOG performance status 0-2
- Informed consent provided.
Key exclusion criteria (3 listed)
- Mupirocin allergy
- Skin or salivary gland malignancy
- Early stage glottic cancers (T1-2N0)
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 |
|---|---|---|
| Mupirocin Ointment [Treatment]1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment | Drug | Mupirocin topical ointment |
| Placebo1 fingertip unit of topical petrolatum ointment (placebo) applied BID to both nares in cyclical week on/off fashion throughout radiation treatment | Drug | Placebo Arm |
Primary outcome
Patient reported pain (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain))
Time frame: Measured weekly for duration of radiation treatment (Maximum 7 weeks)
Severity of pain in mouth or throat, measured on a 0-10 pain scale. Assessed weekly during treatment, using worst noted pain across treatment duration for analysis
6 secondary outcomes
Oral mucositis grade (Radiation Therapy Oncology Group scale 1-4 (Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support))
Time frame: Weekly for duration of radiation (Max 7 weeks)
Quality of life score
Time frame: Measured at treatment start and in final week of treatment (Max 7 weeks)
Treatment interruptions
Time frame: Any treatment interruptions measured at weekly assessment (Max 7 weeks)
Feeding tube insertion
Time frame: Any feeding tube insertion measured at weekly assessment (Max 7 weeks)
Hospital admissions
Time frame: Any hospital admissions measured at weekly assessment (Max 7 weeks)
Morphine adjusted pain score (MAPS)
Time frame: Measured weekly during radiotherapy treatment (Max 7 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 40773220Liao Z, Xiong X, Zhao L, Zhang Z, Guan C, Zhang L, Zhong F, Rao J, Wang X, Xiao Y, Gong X, Huang SH, Li J, Lu T. Bacterial Decolonization With Mupirocin Ointment for Acute Radiation Oral Mucositis Prevention: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 1;11(10):1141-1149. doi: 10.1001/jamaoncol.2025.2361.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcomes will be shared, including weekly odynophagia 11-point numeric rating scale scores, Radiation Therapy Oncology Group mucositis grades, MD Anderson Symptom Inventory scores, morphine-equivalent analgesia data and the derived analgesia-adjusted pain score, and key clinical outcomes (treatment interruptions, feeding tube insertion, hospital admissions), along with baseline demographic and treatment descriptors needed to interpret the dataset (e.g., age group, sex, primary site group, treatment intent, and concurrent systemic therapy category), and adverse event data; no direct identifiers will be shared.
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Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
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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.
David Palma, MD PhD principal investigator
London Health Science Centre
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 Mupirocin Ointment [Treatment] in people with Radiation Mucositis and Staphylococcal Aureus Infection, run by David Palma at 1 site in Canada.
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 4 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: opening soon, as of the sponsor's last update on 1 May 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 Canada. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niall O'Dwyer, MD (+1 5196858500, niall.odwyer@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported pain (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain)) (time frame: Measured weekly for duration of radiation treatment (Maximum 7 weeks)). 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 NCT07524894, 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 1 May 2026.