Nasopharangeal CancerPhase 3NCT07559877
Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma:
A Phase 3 study testing 2% chlorhexidine in people with Nasopharangeal Cancer, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharangeal Cancer
- What is being tested?
- 2% chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2027
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed nasopharyngeal carcinoma. Clinical stage II-III disease with N≥1, according to the UICC/AJCC 9th edition. Planned to receive first-course definitive chemoradiotherapy, with a total radiotherapy dose of 60-70 Gy.
- Able to communicate and complete study assessments. Willing to participate and able to provide written informed consent. Eligible based on baseline assessments performed before chemoradiotherapy.
Who cannot join
- History of or current psychiatric disorder, cognitive impairment, or other severe organic disease.
- Presence of another concomitant malignancy. Receipt of any other prophylactic intervention for radiation dermatitis. Pre-existing skin disease before chemoradiotherapy. Known hypersensitivity or allergy to chlorhexidine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Tianzhu Lu, PhD, 15270186250, lutianzhu2008@163.com
About this study
Official title: Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma: A Phase III Randomized Double-Blind Single-Center Trial
This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.
- Conditions
- Nasopharangeal Cancer
- Being tested
- 2% chlorhexidine, Sterile Water as control
- Keywords
- Radiation Dermatitis Acute, Nasoharyngeal carcinoma, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidineDrug
Topical 2% chlorhexidine spray
Sterile Water as controlDrug
Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | Topical 2% chlorhexidine spray once daily after showering, sprayed evenly over the entire radiation field from a distance of 15-20 cm, starting 1 day before radiotherapy and continuing until 1 week after radiotherapy; stopped when grade ≥2 acute radiation dermatitis occurs. Standard skin care and health education will also be provided. Receives: Drug: 2% chlorhexidine |
| Control intervention | Placebo comparator | Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education. Receives: Drug: Sterile Water as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis
Incidence of Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis based CTCAE v5.0
Measured: Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharangeal 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559877
- Sponsor's protocol ID
- CHANCE Trial
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma: A Phase III Randomized Double-Blind Single-Center Trial
- ClinicalTrials.gov ID
- NCT07559877
- Acronym / sponsor ID
- CHANCE Trial
- Conditions
- Nasopharangeal Cancer
- Keywords
- Radiation Dermatitis Acute, Nasoharyngeal carcinoma, chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 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.
This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Drug: 2% chlorhexidineTopical 2% chlorhexidine spray once daily after showering, sprayed evenly over the entire radiation field from a distance of 15-20 cm, starting 1 day before radiotherapy and continuing until 1 week after radiotherapy; stopped when grade ≥2 acute radiation dermatitis occurs. Standard skin care and health education will also be provided. |
| Control intervention | Placebo comparator | Drug: Sterile Water as controlTopical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed nasopharyngeal carcinoma. Clinical stage II-III disease with N≥1, according to the UICC/AJCC 9th edition. Planned to receive first-course definitive chemoradiotherapy, with a total radiotherapy dose of 60-70 Gy.
- Able to communicate and complete study assessments. Willing to participate and able to provide written informed consent. Eligible based on baseline assessments performed before chemoradiotherapy.
Key exclusion criteria (2 listed)
- History of or current psychiatric disorder, cognitive impairment, or other severe organic disease.
- Presence of another concomitant malignancy. Receipt of any other prophylactic intervention for radiation dermatitis. Pre-existing skin disease before chemoradiotherapy. Known hypersensitivity or allergy to chlorhexidine.
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 |
|---|---|---|
| 2% chlorhexidineTopical 2% chlorhexidine spray | Drug | Experimental intervention |
| Sterile Water as controlTopical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education. | Drug | Control intervention |
Primary outcome
Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis
Time frame: Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy
Incidence of Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis based CTCAE v5.0
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 30 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% chlorhexidine in people with Nasopharangeal Cancer, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Apr 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tianzhu Lu, PhD (+8615270186250, lutianzhu2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis (time frame: Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy). 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 30 Apr 2026.